guidelines for blood bank

8/11/2019 Guidelines for Blood Bank

1/60

REGULATORY REQUIREMENTS OF BLOOD AND/OR ITS COMPONENTS

INCLUDING BLOOD PRODUCTS

INTRODUCTION

Blood Transfusion Service is a vital part of the National Health Service and

there is no substitute for Human Blood and its components. Increasing advancement

in the field of Transfusion Technology has necessitated to enforce stricter control over

the quality of Blood and its products. In most of the developed countries, the blood

banking system has advanced in all facets of donor management, storage of blood,

grouping and cross matching, testing of transmissible diseases, rationale use of blood

and distribution. The ovt. has the full responsibility for the blood programme even

though, in some countries, the management of blood transfusion services are

delegated fully or partly to an appropriate non!governmental organi"ation #N$s%

&orking on a non!profit basis, e.g. 'ed (ross Society. )hen a N$ is assigned thisresponsibility, the ovt. should formally recogni"e it and give a clear mandate

formulating the national blood policy, it is important to consider policy decisions

enforcing appropriate regulations or necessary functions of health service to ensure

high quality service and safe blood.

In order to improve the standards of Blood and its components, the (entral

ovt. through *rugs (ontroller eneral of India, has formulated a comprehensive

legislation to ensure better quality control system on collection, storage, testing and

distribution of blood and its components. (entral ovt. amended from time to time

the e+isting requirements of Blood Banks in the *rugs (osmetics -ct, /01 and'ules thereunder to meet the latest standards. (onsequent to a public litigation case

recently, Supreme (ourt of India directed (entral ovt. to enact a comprehensive

legislation on Blood Banks in collection, storage, testing and distribution of blood and

its components. In this conte+t, the office of *rugs (ontroller eneral of India

made draft rules to further amend the e+isting la& in the *rugs (osmetics -ct,

/01 and 'ules thereunder to meet the direction of Hon2ble Supreme (ourt in order to

improve the blood banking system in the country.

NATIONAL BLOOD POLICY

overnment of India published in the year 3113 the National Blood

4olicy. The ob5ective of the policy is to provide safe, adequate quantity of blood,

blood components and products. The main aim of the policy is to procure non

remunerated regular blood donors by the blood banks. The policy also addresses

various issues &ith regard to technical personnel, research , development and to

eliminate profiteering by the blood banks by selling blood. The policy also envisages


2/60

that fresh licences to stand alone blood banks in private sector shall not be granted and

rene&al of such blood banks shall be sub5ected to thorough scrutiny.

SCENARIO OF LEGAL FRAMEWORK

Human blood is covered under the definition of 6*rug2 under Sec. 7#b% of *rugs (osmetics -ct. Hence, it is imperative that Blood Banks need to be regulated under

the *rugs (osmetics -ct and rules thereunder.

In the year /89, (entral ovt. #:inistry of Health% enacted a separate

provision in Schedule ; 4art (osmetics 'ules, /0. The 'ules from 33; to 334 e+plain the various procedure

of making applications by a blood bank, fees to be paid for grant@rene&al of licence


3/60

by the applicant and conditions of licence to be follo&ed by the applicant after

grant@rene&al and conditions of licence to be follo&ed by the applicant after

grant@rene&al of licnece.

In accordance &ith the Supreme (ourt order, blood bank legislation has been

e+tensively revised on .0./// to include ood :anufacturing 4ractices, Standard$perating 4rocedure and validation of equipments etc. The brief requirements for

grant@rene&al of blood bank licences are as follo&sC

PART X-B

REQUIREMENTS FOR THE COLLECTION, STORAGE, PROCESSING AND

DISTRIBUTION OF WHOLE HUMAN BLOOD, HUMAN BLOOD COMPONENTS BY

BLOOD BANKS AND MANUFACTURE OF BLOOD PRODUCTS

122-EA. De!"!#!$"%.! #% In this 4art and in the ;orms contained in Schedule - andin 4art


4/60

of blood assurance programme, gifts or little or intrinsic monetary value shall not be

construed as considerationE

#h% 6leucapheresis2 means the process by &hich the blood dra&n from a donor,

after leucocyte concentrates have been separated, is re!transfused

simultaneously into the said donorE#i% 6plasmapheresis2 means the process by &hich the blood dra&n from a donor,

after plasma has been separated, is re!transfused during the same sitting into the

said donorE

#5% 6plateletpheresis2 means the process by &hich the blood dra&n from a donor,

after platelet concentrates have been separated, is re!transfused simultaneously

into the said donor.

#k% 6professional donor2 means a person &ho donates blood for a

valuable consideration, in cash or kind, from any source, on behalf of the

recipient D patient and includes a paid donor or a commercial donorE

(l) 6replacement donor2 means a donor &ho is a family friend or a relative of thepatient Drecipient.

122-F. F$&' $ ())*!+(#!$" $& *!+e"+e $& $)e&(#!$" $ B*$$ B("/)&$+e%%!" $

0$*e 0'(" *$$ $& +$')$"e"#%/'("(+#&e $& B*$$ P&$+#% $& %(*e $&

!%#&!#!$" #% -pplication for the grant and@or rene&al of licence for theoperation of Blood Bank@processing of Human Blood for components@manufacture of

Blood 4roducts shall be made to the Aicensing -uthority appointed under 4art =II in

;orm 39!( or ;orm 39!F as the case may be and shall be accompanied by licence feesof rupees si+ thousand and an inspection fees of rupees one thousand and five hundred

for every inspection thereof or for the purpose of rene&al of licence.

4rovided that if the applicant applies for rene&al of licence after the e+piry but

&ithin si+ months of such e+piry the fee payable for the rene&al of the licnece shall

be rupees si+ thousand and inspection fees of rupees one thousand and five hundred

plus an additional fees at the rate of rupees one thousand per month or a part thereof

in additional to the inspection fee.

4rovided further that a licensee holding a licence in ;orm 3>!( or ;orm 3>!F asthe case may be for operation of blood bank@processing of &hole human blood for

components@manufacture of blood products shall apply for grant of licence under sub!

rule #% before the e+piry of the said licnece on ;orm 39!( or ;orm 39!F as the case

may be and he shall continue to operate the same till the orders on his application are

communicated to him.


5/60

. GF


6/60

4rovided that if the (entral Aicence -pproving -uthority is of the

opinion that the applicant is not in a position to fulfill the requirements

laid do&n in these rules he may, not&ithstanding the report of the

Aicensing -uthority, by order, for reason to be recorded in the &riting,

re5ect the application for grant or rene&al of licence as the case may be

and shall supply the applicant &ith a copy of the inspection report.

33!. ;orm of licence for the operation of a Blood Bank@4rocessing of )hole

Human Blood for components and manufacture of Blood products and the conditions

for the grant or rene&al of such licence.! - licence for the operation of a Blood Bank

or for processing &hole Human Blood for components and manufacture of blood

products shall be issued in ;orm 3>!( or ;orm!3>!F or ;orm 38! or ;orm 38!I as

the case may be. Before a licence in ;orm 3>!( or ;orm!3>!F or ;orm 38! or ;orm

38!I, as the case may be, is granted or rene&ed the follo&ing conditions shall be

complied &ith by the applicant.!

#i% The operation of the Blood Bank and@or processing of &hole human

blood for components@manufacture of blood product shall be carried

out under the active direction and personal supervision of component

technical staff consisting of at least one person &ho is &hole time

employee and &ho is a :edical $fficer, and possessing!

a% 4ost raduate degree in :edicine!:.*.

#4athology@Transfusion :edicines%E or

b% *egree in :edicine #:.B.B.S.% &ith *iploma in 4athology

or Transfusion :edicines having adequate kno&ledge inblood group serology, blood group methodology and

medical principles involved in the procurement of blood

and@or preparation of its componentsE or

c% *egree in :edicine #:.B.B.S.% having e+perience in Blood

Bank for one year during regular service and also has

adequate kno&ledge and e+perience in blood group

serology, blood group methodology and medical principles

involved in the procurement of blood and@or preparation of

its components,

the degree or diploma being from a university recogni"ed by the(entral overnment.

F


7/60

(entral Aicence -pproving -uthority prior to the commencement

of the *rugs (osmetics #Second -mendment% 'ules,///.

#ii% The applicant shall provide adequate space, plant and equipment for

any or all the operations of blood collection or blood processing. The

space, plant and equipment required for various operations is given inSchedule 6;2, 4art DF is granted or a rene&al of

licence in ;orm 38! or ;orm 38!I is made ,as the case may be, the Aicensing

-uthority or (entral Aicence -pproving -uthority, as the case may be , shall cause

the establishment in &hich Blood Bank is proposed to be operated@ &hole human

blood for component is processed@J blood products are manufactured to be inspected

by one or more inspectors, appointed under the -ct and @ or along &ith the F+pert in

the field concerned. The Inspector or Inspectors shall e+amine all portions of the

premises and appliances@ equipments and inspect the process of manufacture intended

to be employed or being employed along &ith the means to be employed or being

employed for operation of blood bank@processing of &hole human bloodfor components@ manufacture of blood products together &ith their testingJ facilities

and also enquire into the professional qualification of the e+pert staff and other

technical staff to be employed.

33!K. 'eport by Inspector.! The Inspector or Inspectors shall for&ard a detailed

descriptive report giving his finding on each aspect of inspection along &ith his


8/60

recommendation in accordance &ith the provisions of 'ule 33!I to the Aicensing

-uthority or to the (entral Aicence -pproving -uthority.

33!L. ;urther application after re5ection.! If &ithin a period of si+ months from the

re5ection of application for a licence the applicant informs the licensing -uthority that

the conditions laid do&n have been satisfied and deposits an inspection fee of rupeest&o hundred and fifty the Aicensing -uthority, if after causing further inspection to be

made is satisfied that the conditions for the grant of a licence have been complied

&ith, shall grant or rene& a licence in ;orm 3>!( or ;orm 3> DFE

4rovided that in case of drug notified by the (entral overnment under

rule 8>!-, the application , together &ith the inspection report and the ;orm of licence

#in triplicate to be granted or rene&ed%, duly completed shall be sent, to the (entral

Aicence -pproving -uthority, &ho may approve the same and return it to the licensing

-uthority for issue of the licence.

33!A. *elegation of po&ers by the (entral Aicensing -pproving -uthority.! The

(entral Aicensing -pproving -uthority may, &ith the approval of the (entral

overnment, by notification delegate his po&er of signing licences and any other

po&er under rules to persons under his control having same qualifications as

prescribed for (ontrolling -uthority under 'ule 1!-, for such areas and for such

periods as may be specified.

33!:. 4rovision for appeal to the State overnment by a 4arty &hose licence has

not been granted or rene&ed.! -ny person &ho is aggrieved by the order passed by theAicensing -uthority or (entral Aicence -pproving -uthority, as the case may be, may

&ithin thirty days from the date of receipt of such order, appeal to the State

overnment or (entral overnment, as the case may be, after such enquiry, into the

matter as it considers necessary and after giving the said person an opportunity for

representing his vie& in the matter may pass such order in relation thereto as it thinks

fit.

33!N. additional information to be furnished by an applicantJ for licence or by a

licensee to the Aicensing -uthority.! The applicant for the grant of licence or any

person granted a licence under the part shall, on demand furnish to the Aicensing-uthority, before the grant of the licence or during the period the licence is in force as,

as the case may be, documentary evidence in respect of the o&nership or occupation,

rental or other basis of the premises, specified in the application for licence or in the

licence granted, constitution of the firm or any other relevant matter, &hich may be

required for the purpose of verifying the correctness of the statement made by the


9/60

applicant or the licensee, &hile applying for or after obtaining the licence, as the case

may be.

33!$.(ancellation and suspension of licences.! #% The Aicensing -uthority or

(entral Aicence -pproving -uthority may for such licences granted or rene&ed by

him after giving the licensee an opportunity to sho& cause by such an order shouldnot be passed by an order in &riting stating the reason thereof, cancel a licence issued

under this part or suspend it for such period as he thinks fit, either &holly or in respect

of some of the substances to &hich it relates, or direct the licensee to stop collection,

storage, processing, manufacture and distribution of the said substances and

thereupon order the destruction of substances andJ stocks thereof in the presence of

an InspectorJ if in his opinion, the licensee has failed to comply &ith any of the

conditions of the licence or &ith any provision of the -ct or 'ules thereunder.

#3% - licensee &hose licence has been suspended or cancelled, &ithin

three months of the date of the order under sub!rule #% prefer an appeal against that

order to the State overnment or (entral overnment, &hich shall decide the same.

33!4. (onditions of licence! - licence in ;orm 3>!(, ;orm 3>!F, ;orm 38! or ;orm

38!I shall be sub5ect to the special conditions set out in Schedule ;, 4art


10/60

&hole human blood collected by him in adequate quantity

to conduct all the prescribed tests. The licensee shall supply

to the Inspector the reference sample for the purpose of

testing.

#ii% The licensee shall allo& an inspector appointed under the-ct to enter, &ith or &ithoutJ prior notice, any premises

&here the activities of the Blood Bank are being carried

out, for the processing of )hole Human Blood and@or

Blood 4roducts, to inspect the premises and plant and the

process of manufacture and the means employed for

standardi"ing and testing the substance.

#iii% The licensee shall allo& an Inspector appointed under the

-ct to inspect all registers and records maintained under

these rules and to take samples of the manufactured product

and shall supply to Inspector such information as he may

require for the purpose of ascertaining &hether the

provisions of the -ct and 'ules thereunder have been

observed.

#iv% The licensee shall from time to time report to the

Aicensing -uthority any changes in the e+pert staff

responsible for the operation of a Blood Bank@processing of

&hole human blood for components and@or manufacture ofblood products and any material alterations in the premises

or plant used for that purpose &hich have been made since

the date of last inspection made on behalf of the Aicensing

-uthority before the grant of the licence.

#v% The licensee shall on request furnish to the Aicensing

-uthority, or (entral Aicence -pproving -uthority or to

such -uthority as the Aicensing -uthority, or the (entral

Aicence -pproving -uthority may direct, from any batch

unit of drugs as the Aicensing -uthority or the (entralAicence -pproving may from time to time specify, sample

of such quantity as may be considered adequate by such

-uthority for any e+amination and, if so required, also

furnish full protocols of the test &hich have been applied.


11/60

#vi% If the Aicensing -uthority or the (entral Aicence

-pproving -uthority so directs, the licensee shall not sell

or offer for sale any batch@unit in respect of &hich a sample

is, or protocols are furnished under the last preceding sub!

paragraph until a certificate authori"ing the sales of

batch@unit has been issued to him by or on behalf of theAicensing -uthority or the (entral Aicence -pproving

-uthority.

#vii% The licensee shall on being informed by the Aicensing

-uthority or the (ontrolling -uthority that any part of any

batch@unit of the substance has been found by the Aicensing

-uthority or the (entral Aicence -pproving -uthority not

to conform &ith the standards of strength, quality or purity

specified in these 'ules and on being directed so to do so,

&ithdra&, from sales and so far as may in the particular

circumstances of the case be practicable recall all issues

already made from that batch@unit.

#viii% No drug manufactured under the licence shall be sold

unless the precautions necessary for preserving its

properties have been observed throughout the period after

manufacture. ;urther no batch@unit manufactured under this

licence shall be supplied@distributed to any person &ithout

prescription of 'egistered :edical 4ractitioner.

#i+% The licensee shall comply &ith the provisions of the -ct

and of these 'ules and &ith such further requirements, if

any, as may be specified in any 'ules subsequently made

under (hapter I= of the -ct, provided that &here such

further requirements are specified in the 'ules, these &ould

come in force four months after publication in the $fficial

a"ette.

#+% The licensee shall maintain an Inspection Book in ;orm7 to enable an Inspector to record his impressions and

defects noticed.

#+i% The licensee shall destroy the stocks of batch@unit &hich

does not comply &ith standard tests in such a &ay that it


12/60

&ould not spread any disease@infection by &ay of proper

disinfection method.

#+ii% -ll bio!medical &aste shall be treated, disposed off or

destroyed as per the provisions of The Bio!:edical )astes

#:anagement and Handling% 'ules //8.

#+iii% The licensee shall neither collect blood from any

professional donor or paid donor nor shall he prepare blood

components and@or manufacture blood products from the

blood dra&n from such a donor.

F$&' 23-G

#See 'ule 33!;%

CERTIFICATE OF RENEWAL OF LICENCE TO OPERATE A BLOOD BANK FOR

PROCESSING OF WHOLE HUMAN BLOOD AND/OR4 FOR PREPARATION

FOR SALE OR DISTRIBUTION OF ITS COMPONENTS

(ertified that licence number MMMMMMMMMMMMMMMMMMMMMMMMgranted on

MMMMMMMM to :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM for the operation

of a Blood Bank for processing of &hole blood and @ or for preparation of its

components at the premises situated at MMMMMMMMMMMMMMMMMMMMMMM is hereby

rene&ed &ith effect from MMMMMMMMMMMMMMMM to MMMMMMMMMMMMMMMMMMM.

3 Name #s% of Items C

.

3.

7.

7. Name#s% of competent Technical Staff C

.

3.

7.

0.

.

8.

*ated MMMMMMMMMMMMMMMMM Signature MMMMMMMMMMMMMMMMMMMMMMMM

Name and *esignation MMMMMMMMMMMMMMMMMMMM

Aicensing -uthority


13/60

MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM

MMMMMM

(entral Aicence -pproving -uthority

delete, &hichever is not applicable.OE

#b% after ;orm 38!H, the follo&ing ;orm shall be inserted, namely C!

5F$&' 23-I

#See rule 33!I%

CERTIFICATE OF RENEWAL OF LICENCE FOR

MANUFACTURE OF BLOOD PRODUCTS

(ertified that licence number MMMMMMMMMMMMMMMMMMMMMMMMgranted on

MMMMMMMMMMM to :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMM for manufacture of

blood products at the premises situated at MMMMMMMMMMMMMMMMMM is hereby

rene&ed &ith effect from MMMMMMMMMMMMM to MMMMMMMMMMMMMMMMMMM.

3. Name#s% of item#s% C

.

3.

7.

7.

Names of competent Technical Staff C#a% responsible for manufacturing #b% responsible for

testing

. .

3. 3.

7. 7.

0. 0.

Signature MMMMMMMMMMMMMMMMMM

Name and *esignation MMMMMMMMMMMMMM

Aicensing -uthority

MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM

(entral Aicence -pproving -uthorityO.E


14/60

#c% for ;orm 39!(, the follo&ing form shall be substituted, namelyC!

5F$&' 26-C

#See rule 33!;%

APPLICATION FOR GRANT / RENEWAL 4 OF LICENCE FOR THE

OPERATION OF A BLOOD BANK FOR PROCESSING OF WHOLE BLOOD

AND/OR4 PREPARATION OF BLOOD COMPONENTS

. I@)e MMMMMMMMMMMMMMMMMMMof

:@sMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMhereby apply for the grant of licence @

rene&al of licence number MMMMMMMMMMMMMMdated MMMMMMMMMMMMMMMMMMMMMMM

to operate a Blood Bank, for processing of &hole blood and@or for preparation

of its components on the premises situated at

MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM.

3. Name#s% of the item#s%C

.

3.

7.

7. The name#s%, qualification and e+perience of competent Technical Staff

are as

under C

#a% Name#s% of :edical $fficer.

#b% Name#s% of Technical Supervisor.

#c% Name#s% of 'egistered Nurse.

#d% Name#s% of Blood Bank Technician.

0. The premises and plant are ready for inspection@ &ill be ready for inspectionon

MMMMMMMMMMMMMMMMMMMMMMM.

. - licence fee of rupees MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM and an

inspection fee of rupees MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM has been


15/60

credited to the overnment under the Head of -ccount

MMMMMMMMMMMMMMMMMMMMMMM #receipt enclosed%.

Signature

MMMMMMMMMMMMMMMMMMMMMMMMMMMM

*ated MMMMMMMMMMMMMMM Name and *esignation

MMMMMMMMMMMMMMMMMMM

delete, &hichever is not applicable.

Note . The application shall be accompanied by a plan of the premises,

list of machinery and equipment for collection, processing,

storage and testing of &hole blood and its components,

memorandum of association@ constitution of the firm, copies of

certificate relating to educational qualifications and e+perience of

the competent technical staff and documents relating to o&nership

or tenancy of the premises.

3. - copy of the application together &ith the relevant enclosures

shall also be sent to the (entral Aicence -pproving -uthority and

to the concerned ?onal@Sub! ?onal $fficers of the (entral *rugs

Standard (ontrol $rgani"ation.OE

#d% after ;orm 39!*, the follo&ing ;orm shall be inserted, namely C!

5F$&' 26-E

#See rule 33!;%

APPLICATION FOR GRANT/RENEWAL4OF LICENCE TO MANUFACTURE

BLOOD PRODUCTS FOR SALE OR DISTRIBUTION

. I@)e MMMMMMMMMMMMMMMMMMMMof :@sMMMMMMMMMMMMMMMMMMMMMMMMMMMhereby

apply for the grant of licence@rene&al of licence number MMMMMMMMMMMMMMMMMMMMM

dated MMMMMMMMMMMMMMMMMMMMM to manufacture blood products on the premises

situated at MMMMMMMMMMMMMMMMMMMMMM

3. Name#s% of item#s% C

.

3.

7.


16/60

0.

7. The name#s%, qualification and e+perience of competent Technical Staff

as under C

#a% responsible for manufacturing #b% responsible for

testing

. .

3. 3.

7. 7.

0. The premises and plant are ready for inspection @ &ill be ready for inspection

onMMMMMMMMMMMMMMMMMMMMMMMMMMMM

. - licence fee of rupees MMMMMMMMMMMMMMand an inspection fee of rupees

MMMMMMMMMMMMMMMMMMMMMMMMMMM has been credited to the overnment under the

Head of -ccount MMMMMMMMMMMMMMMMM #receipt enclosed%,

*ated MMMMMMMMMMMM signature MMMMMMMMMMMMMMMMMMMMMMMM

Name *esignation

MMMMMMMMMMMMMMM

delete, &hichever is not applicable.

N$TF . The application shall be accompanied by a plan of the premises, list of

machinery and equipment for manufacture of blood products,

memorandum of association@constitution of the firm, copies of certificate

relating to educational qualifications and e+perience of the competent

technical staff and documents relating to o&nership or tenancy of the

said premises.

3. - copy of the application together &ith the relevant enclosures shall

also be sent to the (entral Aicence -pproving -uthority and to the

concerned ?onal @ Sub ?onal $fficers of the (entral *rugs Standard

(ontrol $rganisation.OE

#e% for ;orm 3>!(, the follo&ing ;orm shall be substituted, namely C!

5F$&' 27-C

#See rule 33!%


17/60

LICENCE TO OPERATE A BLOOD BANK FOR COLLECTION, STORAGE

AND

PROCESSING OF WHOLE HUMAN BLOOD AND/OR4 ITS COMPONENTS

FOR

SALE OR DISTRIBUTION

. Number of licence MMMMMMMMMMMMMMMMMMMMM date of issue

MMMMMMMMMMMMMMMMat

the premises situated at MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM

3. :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM is hereby licensed to

collect, store, process and distribute &hole blood and @ or its components.

7. Name#s% of the item#s% C

.

3.

7.


.

3.

7.

0.

.

8.

. The licence authori"es licensee to manufacture, store, sell or distribute the

blood products, sub5ect to the conditions applicable to this licence.

8. The licence shall be in force from MMMMMMMMMMMM to MMMMMMMMMMMMM

9. The licence shall be sub5ect to the conditions stated belo& and to such other

conditions as may be specified from time to time in the 'ules made under the

*rugs and (osmetics -ct, /01.

*ated MMMMMMMMMMMMM Signature

MMMMMMMMMMMMMMMMMMMMMMMM

Name and *esignation

MMMMMMMMMMMMM

Aicensing -uthority

MMMMMMMMMMMMMMMMMMMMMMMMMMM

MMMMM


18/60

(entral Aicence -pproving

-uthority

delete, &hichever is not applicable

CONDITIONS OF LICENCE

. The licensee shall neither collect blood from any professional donor nor

paid donor nor shall he prepare blood components from the blood collected

from such a donor.

3. The licence and any certificate of rene&al in force shall be displayed on the

approved premises and the original shall be produced at the request of an

Inspector appointed under the *rugs and (osmetics -ct, /01.

7. -ny change in the technical staff shall be forth&ith reported to the Aicensing

-uthority and @ or (entral Aicence -pproving -uthority.

0. The licensee shall inform the Aicensing -uthority and@or (entral Aicence

-pproving -uthority in &riting in the event of any change in the constitution of

the firm operating under the licence. )here any change in the constitution of

the firm takes place, the current licence shall be deemed to be valid for

ma+imum period of three months from the date on &hich the change has taken

place unless, in the meantime, a fresh licence has been taken from the

Aicensing -uthority and@or (entral Aicence -pproving -uthority in the name

of the firm &ith the changed constitution.OE

#f% after ;orm 3>!*, the follo&ing ;orm shall be inserted, namely C!

5F$&' 27-E

#See rule 33!%

LICENCE TO MANUFACTURE AND STORE BLOOD PRODUCTS FOR

SALE OR DISTRIBUTION

. Number of licence MMMMMMMMMMMMMMMMMMMMM date of issue

MMMMMMMMMMMMMMMMat

the premises situated at MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM

3. :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMis hereby licensed to

manufacture, store, sell or distribute the follo&ing blood products C!

7. Name#s% of the item#s% C

.

3.

7.

0.

.


19/60


#a%responsible for manufacturing #b% responsible for testing

. .

3. 3.

7 7.

. The licence authori"es licensee to manufacture, store, sell or distribute theblood products, sub5ect to the conditions applicable to this licence.

8. The licence shall be in force from MMMMMMMMMMMMMMMMMMMMM to

MMMMMMMMMMMMM

9. The licence shall be sub5ect to the conditions stated belo& and to such other

conditions as may be specified from time to time in the 'ules made under the

*rugs and (osmetics -ct, /01.

*ated MMMMMMMMMMMMM Signature

MMMMMMMMMMMMMMMMMMMMMMMM

Name and *esignation

MMMMMMMMMMMMM

Aicensing -uthority

MMMMMMMMMMMMMMMMMMMMMMMMMMM

MM

(entral Aicence -pproving

-uthority

delete, &hichever is not applicable

CONDITIONS OF LICENCE. The licensee shall not manufacture blood products from any professional

donor or paid donor.

3. This licence and any certificate of rene&al in force shall be displayed on the

approved premises and the original shall be produced at the request of an

Inspector appointed under the *rugs and (osmetics -ct, /01.

7. -ny change in the technical staff shall be forth&ith reported to the Aicensing

-uthority and @ or (entral Aicence -pproving -uthority.

0. The licensee shall inform the Aicensing -uthority and@ or (entral Aicence

-pproving -uthority in &riting in the event of any change in the constitution ofthe firm, operating under the licence. )here any change in the constitution of

the firm takes place, the current licence shall be deemed to be valid for

ma+imum period of three months from the date on &hich the change has taken

place unless, in the meantime, a fresh licence has been taken from the

Aicensing -uthority and@or (entral Aicence -pproving -uthority in the name

of the firm &ith the changed constitution.E


20/60

5PART XII BREQUIREMENTS FOR THE FUNCTIONING AND OPERATION OF A BLOOD

BANK AND / OR FOR PREPARATION OF BLOOD COMPONENTS.

I. BLOOD BANKS / BLOOD COMPONENTS

A. GENERAL

. Aocation and Surroundings C The blood bank shall be located at a place &hich

shall be a&ay from open se&age, drain, public lavatory or similar unhygienic

surroundings.

3 Building C The building #s%, used for operation of a blood bank and@or

preparation of blood components shall be constructed in such a manner so as to

permit the operation of the blood bank and preparation of blood components

under hygienic

conditions and shall avoid the entry of insects, rodents and flies. It shall be

&ell lighted, ventilated and screened #mesh%, &herever necessary. The &alls

and floors of the rooms, &here collection of blood or preparation of blood

components or blood products is carried out shall be smooth, &ashable and

capable of being kept clean. *rains shall be of adequate si"e and &here

connected directly to a se&er, shall be equipped &ith traps to prevent back

siphonage.

7. Health, clothing and sanitation of staff C The employees shall be free

from contagious or infectious diseases. They shall be provided &ith clean

overalls, head!gears, foot!&ears and gloves, &herever required. There shall be

adequate, clean and convenient hand &ashing and toilet facilities.

B. ACCOMODATION FOR A BLOOD BANK 8

- blood bank shall have an area of 11 square meters for its operations and

an additional area of 1 square meters for preparation of blood components. It

shall be consisting of a room each for D

#% 'egistration and medical e+amination &ith adequate furniture and facilities

for registration and selection of donorsE

#3% blood collection #air!conditioned%E


21/60

#7% blood component preparation. #This shall be air!conditioned to maintain

temperature bet&een 31 degree centigrade to 3 degree centigrade%E

#0% laboratory for blood group serology. #air!conditioned%

#% laboratory for blood transmissible diseases like Hepatitis, Syphilis, :alaria,HI=!antibodies #air!conditioned%E

#8% sterili"ation!cum!&ashingE

#9% refreshment!cum!rest room #air!conditioned%E

#>% store!cum!records.

NOTES 8

#% The above requirements as to accommodation and area may be

rela+ed, In respect of testing laboratories and sterili"ation!cum!

&ashing room, for reasons to be recorded in &riting by the Aicensing

-uthority and @ or the (entral Aicence -pproving -uthority, in

respect of blood banks operating in Hospitals, provided the hospital

concerned has a pathological laboratory and a sterili"ation!cum!

&ashing room common &ith other departments in the said hospital.

#3% 'efreshments to the donor after phlebotomy shall be served so that

heis kept under observation in the Blood Bank.

C. PERSONNEL

Fvery blood bank shall have follo&ing categories of &hole time competent

technical staff C!

#a% :edical $fficer, possessing the qualifications specified in condition

of rule 33!.

#b% Blood Bank Technician#s% ,possessing !#i% *egree in :edical Aaboratory Technology #:.A.T.% &ith si+

monthsP e+perience in the testing of blood and@or its

componentsE or

#ii% *iploma in :edical Aaboratory Technology #:AT% &ith

one yearPs e+perience in the testing of blood and@or its

components, the degree or diploma being from a


22/60

Qniversity@Institution recognised by the (entral overnment

or State overnment.

#c% 'egistered Nurse#s%.

#d% Technical Supervisor#&here blood components are manufactured%,possessing !

#i% *egree in :edical Aaboratory Technology #:.A.T.% &ith si+

monthsP e+perience in the preparation of blood componentsE

or

#ii% *iploma in :edical Aaboratory Technology #:.A.T% &ith

one yearPs e+perience in the preparation of blood

components, the degree or diploma being from a

Qniversity@Institution recognised by the (entral overnment

or State overnment.

NOTES8

#% The requirements of qualification and e+perience in respect of Technical

Supervisor and Blood Bank Technician shall apply in the cases of persons

&ho are approved by the Aicensing -uthority and@or (entral Aicence

-pproving -uthority after the commencement of the *rugs and

(osmetics# -mendment% 'ules, ///.

#3% -s regards, the number of &hole time competent technical personnel, the

blood bank shall comply &ith the requirements laid do&n in the *irectorateeneral of Health Services :anual.

#7% It shall be the responsibility of the licensee to ensure through maintenance

of records and other latest techniques used in blood banking system that the

personnel involved in blood banking activities for collection, storage,

testing and distribution are adequately trained in the current ood

:anufacturing 4ractices@Standard $perating 4rocedures for the tasks

undertaken by each personnel. The personnel shall be made a&are of the

principles of ood :anufacturing 4ractices@Standard operating 4rocedures

that affect them and receive initial and continuing training relevant to their

needs.

D. MAINTENANCE 9

The premises shall be maintained in a clean and proper manner to ensure

adequate cleaning and maintenance of proper operations. The facilities shall

include D


23/60

# % 4rivacy and thorough e+amination of individuals to determine their suitability

as donors.

#3% (ollection of blood from donors &ith minimal risk of contamination or

e+posure toactivities and equipment unrelated to blood collection.

#7% Storage of blood or blood components pending completion of tests.

#0% 4rovision for quarantine, storage of blood and blood components in a

designated location, pending repetition of those tests that initially give

questionable serological results.

#% 4rovision for quarantine, storage, handling and disposal of products and

reagents not suitable for use.

#8% Storage of finished products prior to distribution or issue.

#9% 4roper collection, processing, compatibility testing, storage and distribution of

blood and blood components to prevent contamination.

#>% -dequate and proper performance of all procedures relating to

plasmapheresis, plateletpheresis and leucapheresis.

#/% 4roper conduct of all packaging, labeling and other finishing operations.

#1% 4rovision for safe and sanitary disposal of D

#i% Blood and@or blood components not suitable for use, distribution or

sale.

#ii% Trash and items used during the collection, processing and

compatibility

testing of blood and@or blood components.

E. EQUIPMENT 8

Fquipment used in the collection, processing, testing, storage and sale@distribution of

blood and its components shall be maintained in a clean and proper manner and so

placed as to facilitate cleaning and maintenance. The equipment shall be observed,

standardised and calibrated on a regularly scheduled basis as described in the Standard


24/60

$perating 4rocedures :anual and shell operate in the manner for &hich it &as

designed so as to ensure compliance &ith the official requirements #the equipments%

as stated belo& for blood and its components.

Fquipment that shall be observed, standardised and calibrated &ith at least the

follo&ing frequencies C!

FRQI4:FNT 4F';$':-N(F ;'FRQFN( ;'FRQFN( $;(-AIB'-TI$N

. Temperature recorder (ompare against

thermometer

*aily -s often as necessary

3. 'efrigeratedcentrifuge

$bserve speed andtemperature

Fach day of use -s often as necessary

7. Hematocrit

centrifuge

!! !! Standardise before

initial use, after repair or

ad5ustments, andannually.

0. eneral

lab. centrifuge!! !! Tachometer. every 8

months,

. -utomated Blood

typing

$bserve controls for

correct results

Fach day of use !!!

8. Haemoglo! bihometer Standardi"e

against cyanamethemo!

globulin standard

Fach day of use !!!

9. 'efractiometer or

Qrinometer

Standardi"e against

distilled &ater .

!!!ditto

!!!

!!!

>. Bloodcontainer &eighing

device

standardi"e againstcontainer of kno&n

&eight

!!!ditto !! -s often as necessary,

/. )ater Bath $bserve Temperature !!!ditto

!!

!!!!ditto!!!!

1. 'h vie& bo+#&herever

necessary%

!!ditto !! !!ditto!! !!!!ditto!!!!

. -utoclave !!ditto !! Fach timeof use

!! ditto !!

3. serologic rotators $bserve controls for

correct results

Fach day of use speed as often as

necessary7. Aaboratory

thermometers

!! !! Before initial use

0. Flectronic

thermometers

!! :onthly !!

. Blood agitator $bserve &eight of the

first container of blood

filled for correct results

Fach day of use standardi"e &ith

container of kno&n mass

or volume before initial


25/60

use, and after repairs or

ad5ustments.

F. SUPPLIES AND REAGENTS8

-ll supplies and reagents used in the collection, processing, compatibility,testing, storage and distribution of blood and blood components shall be stored at

proper temperature in a safe and hygienic place, in a proper manner and in particular D

#a% all supplies coming and contact &ith blood and blood components intended

for

transfusion shall be sterile, pyrogen!free, and shall not interact &ith the product

in such a manner as to have an adverse effect upon the safety, purity, potency or

effectiveness of the product.

#b% supplies and reagents that do not bear an e+piry date shall be stored in amanner

that the oldest is used first.

#c% supplies and reagents shall be used in a manner consistent &ith instructions

provided by the manufacturer .

#d% all final containers and closures for blood and blood components not intended

for

transfusion shall be clean and free of surface solids and other contaminants.

#e% each blood collecting container and its satellite container#s%, if any, shall be

e+amined visually for damage or evidence of contamination prior to its use and

immediately after filling. Such e+amination shall include inspection for

breakage of seals, &hen indicated, and abnormal discoloration. )here any

defect is observed, the container shall not be used or, if detected after filling,

shall be properly discarded.

#f% representative samples of each lot of the follo&ing reagents and@or solution

shall

be tested regularly on a scheduled basis by methods described in the Standard

$perating 4rocedures :anual to determine their capacity to perform as

required C

'eagents and solutions ;requency of testing

along&ith controls


26/60

-nti!human serum Fach day of use

Blood grouping serums Fach day of use

Aectin Fach day of use

-ntibody screening and reverse Fach day of use

grouping cells

Hepatitis test reagents Fach runSyphilis serology reagents Fach run

Fn"ymes Fach day of use

HI= I and II reagents Fach run

Normal saline #AISS and 4BS% Fach day of use

Bovine -lbumin Fach day of use

G. GOOD MANUFACTURING PRACTICES :GMP%;/STANDARD

OPERATING

PROCEDURES :SOP%;8

)ritten Standard $perating 4rocedures shall be maintained and shall include

all

steps to be follo&ed in the collection, processing, compatibility testing, storage and

sale or distribution of blood and@or preparation of blood components for homologous

transfusion, autologous transfusion and further manufacturing purposes. Such

procedures shall be available to the personnel for use in the concerned areas. The

Standard $perating 4rocedures shall inter alia include C

.

#a% criteria used to determine donor suitability.

#b% methods of performing donor qualifying tests and measurements

Including minimum and ma+imum values for a test or procedure,

&hen a factor in determining acceptabilityE

#c% solutions and methods used to prepare the site of phlebotomy so

as to give ma+imum assurance of a sterile container of bloodE

#d% method of accurately relating the product#s% to the donorE

#e% blood collection procedure, including in!process precautions

taken to measure accurately the quantity of blood dra&n from the

donorE

#f% methods of component preparation including, any time

restrictions for specific steps in processingE


27/60

#g% all tests and repeat tests performed on blood and blood

components during processingE

#h% pre!transfusion testing, &herever applicable,

including precautions to be taken to identify accurately therecipient blood components during processingE

#i% procedures of managing adverse reactions in donor and recipient

reactions

#5% storage temperatures and methods of controlling storage

temperatures for blood and its components and reagentsE

#i% length of e+piry dates, if any, assigned for all final productsE

#I% criteria for determining &hether returned blood is suitable for re!

issueE

#m% procedures used for relating a unit of blood or blood component

from the donor to its final disposalE

#n% quality control procedures for supplies and reagents employed in

blood collection, processing and re!transfusion testingE

#o% schedules and procedures for equipment maintenance and

calibrationE

#p% labelling procedures to safe guard its mi+!ups, receipt, issue,

re5ected and in!handE

#q% procedures of plasmapheresis, plateletphersis and leucapheresis

if performed, including precautions to be taken to ensure re!

infusion of donorPs o&n cells.

#r% procedures for preparing recovered #salvaged% plasma if

performed, including details of separation, pooling, labeling,

storage

and distribution.


28/60

#s% all records pertinent to the lot or unit maintained pursuant to

these regulations shall be revie&ed before the release or

distribution of a lot or unit of final product. The revie& or

portions of the revie& may be performed at appropriate periods

during or after blood collection, processing, testing and storage -

thorough investigation, including the conclusions and follo&!up,of any une+plained discrepancy or the failure of a lot or unit to

meet any of its specification shall be made and recordedE

3. - licensee may utilise current Standard $perating 4rocedures, such as

the :anuals of the follo&ing organisations, so long as such specific

procedures are consistent &ith, and at least as stringent as, the

requirements contained in this 4art, namely C!

#i% *irectorate eneral of Health Services :anual.

#ii% $ther $rganisations or individual blood bankPs manuals, sub5ect

to the approval of State Aicensing -uthority and (entral Aicence

-pproving -uthority.

H. CRITERIA FOR BLOOD DONATIONC

(onditions for donation of blood C

# % eneral !No person shall donate blood and no blood bank shall dra& blood from a

person, more than once in three months. The donor shall be in good health, mentallyalert and physically fit and shall not be inmates of 5ail, persons having multiple se+

partners and drug!addicts. The donors shall fulfill the follo&ing requirements,

namely C!

#a% the donor shall be in the age group of > to 81 years.

#b% the donor shall not be less than 0 kilogramsE

#c% temperature and 4ulse of the donor shall be normalE

#d% the systolic and diastolic blood pressures are &ithin normal limits

&ithout medicationE

#e% haemoglobin &hich shall not be less than 3. gramsE#f% the donor shall be free from acute respiratory diseasesE

#g% the donor shall be free from any skin diseases at the site of phlebotomy E

#h% the donor shall be free from any disease transmissible by blood transfusion,

insofar as can be determined by history and e+amination indicated aboveE


29/60

#i% the arms and forearms of the donor shall be free from skin punctures or

scars indicative of professional blood donors or addiction of self in5ected

narcotics

#3% -dditional qualifications of a donor. !No person shall donate blood, and no blood

bank shall dra& blood from a donor, in the conditions mentioned in column #%of the Table given belo& before the e+piry of the period of deferment

mentioned in the column #3% of the said Table.

TableC *eferment of blood donation

CONDITIONS PERIOD OF DEFERMENT

#% #3%

#a% -bortions 8 months

#b% History of Blood transfusion 8 months#c% Surgery 3 months

#d% Typhoid 3 months after recovery

#e% History of :alaria and 7 months #endemic%

duly treated 7 years #non endemic area%

#f% Tattoo 8 months

#h% Breast feeding 3 months after delivery

#i% Immuni"ation #(holera, days

Typhoid, *iphtheria,

Tetanus, 4lague,

ammaglobulin%

#5% 'abies vaccination year after vaccination

#k% History of Hepatitis in 3 months

family or close contact

#l% Immunoglobulin 3 months.

#7% No person shall donate blood and no brood bank shall dra& blood from a person,

suffering from any of the diseases mentioned belo&, namely .!

a. (ancer

b. Heart disease

c. -bnormal bleeding tendencies

d. Qne+plained &eight loss

e. *iabetes!controlled on Insulin

f. Hepatitis infection

g. (hronic nephritis

h. Signs and symptoms, suggestive of -I*S


30/60

i. Aiver disease

5. Tuberculosis

k. 4olycythemia =era

l. -sthma

m. Fpilepsy

n. Aeprosyo. Schi"ophrenia

p. Fndocrine disorders

I. GENERAL EQUIPMENTS AND INSTRUMENTSC

. ;or blood collection room C

#i% *onor beds, chairs and tablesC These shall be suitably and comfortably

cushioned and shall be of appropriate si"e.

#ii% Bedside table.

#iii% Sphygmomanometer and Stethoscope.

#iv% 'ecovery beds for donors.

#v% 'efrigerators, for storing separately tested and untested blood, maintaining

temperature bet&een 3 to 8 degree centigrade &ith digital dial thermometer,

recording thermograph and alarm device, &ith provision for continuous

po&er

supply.

#vi% )eighing devices for donor and blood containers.

3.

;or haemoglobin determination C

#i% (opper sulphate solution #specific gravity .17%

#ii% Sterile lancet and impregnated alcohol s&abs.

#ii% (apillary tube #.7+.0+/8 mm or pasteur pipettes%

#iv% 'ubber bulbs for capillary tubings.

#v% SahliPs haemoglobinometer@(olorimeteric method.

7. ;or temperature and pulse determinationC

#i% (linical thermometers.

#ii% )atch #fitted &ith a seconds!hand% and a stop!&atch.

0. ;or blood containers C

#a% $nly disposable 4=( blood bags shall be used #closed system% as per the

specifications of I4@QS4@B4.


31/60

#b% -nti!coagulantsC The anti!coagulant solution shall be sterile, pyrogen!free

and of the follo&ing composition that &ill ensure satisfactory safety and

efficacy of the &hole blood and@or for all the separated blood components.

#i% (itrate 4hosphate *e+trose -denine solution #(4*-% or (itrate

4hosphate

*e+trose -denine! #(4*-!% !!!!0 ml. Solution shall be required for 11ml of blood.

N$TF . #i% In case of single@double@triple@quadruple blood

collection bags used for blood component preparations,

(4*- blood collection bags may be used.

#ii% -cid (itrate *e+trose solution #-.(.* &ith ;ormula!

-%. I.4. !! ml. Solution shall be required for 11ml of

blood.

#iii% -dditive solutions such as S-:, -*S$A,

NQT'I(FA may be used for storing, and retaining 'ed

Blood (orpuscles upto 03 days.

N$TF3. The licensee shall ensure that the anti!coagulant solutions

are of a licensed manufacturer and the blood bags in &hich

the said solutions are contained have a certificate of

analysis of the said manufacturer.

. Fmergency equipments@items .

#i% $+ygen cylinder &ith mask, gauge and pressure regulator.

#ii% percent lucose or Normal Saline.

#iii% *isposable sterile syringes and needles of various si"es.

#iv% *isposable sterile I.=. infusion sets.

#v% -mpoules of -drenaline, Noradrenaline, :ephentin, Betamethasone

or *e+amethasone, :etoclorpropamide in5ections

#vi% -spirin.

8. -ccessories C

#i% Such as blankets, emesis basins, haemostats, set clamps, sponge

forceps, gau"e, dressing 5ars, solution 5ars, &aste cans.

#ii% :edium cotton balls, .3 cm. adhesive tapes.

#iii% *enatured spirit, Tincture Iodine, green soap or liquid soap.

#iv% 4aper napkins or to&els.

#v% -utoclave &ith temperature and pressure indicator.


32/60

#vi% Incinerator

#vii% Stand!by generator.

9. Aaboratory equipmentC

#i% 'efrigerators, for storing diagnostic kits and reagents, maintaining atemperature bet&een 0 to 8 degree ceritigrade #plus@minus 3 degree

centigrade% &ith digital dial thermometer having provision for

continuous po&er supply.

#ii% (ompound :icroscope &ith lo& and high po&er ob5ectives.

#iii% (entrifuge Table :odel

#iv% )ater bathC having range bet&een 79 degree centigrade to 8 degree

centigrade

#v% 'h vie&ing bo+ in case of slide technique.

#vi% Incubator &ith thermostatic control.

#vii% :echanical shakers for serological tests for Syphilis.

#viii% Hand!lens for observing tests conducted in tubes.

#i+% Serological graduated pipettes of various si"es

#+% 4ipettes #4asteur%

#+i% lass slides

#+ii% Test tubes of various si"es@micrometer plates #Q or = type%

#+iii% 4recipitating tubes 8mm+1mm of different si"es and glass

beakers of different si"es

#+iv% Test tube racks of different specifications.

#+v% Interval timer electric or spring &ound. .#+vi% Fquipment and materials for cleaning glass &ares adequately.

#+vii% Insulated containers for transporting blood, bet&een 3 degree

centigrade to 1 degree centigrade temperatures, to &ards and

hospitals.

#+viii% )ash bottles

#+i+% ;ilter papers

#++% *ielectric tube sealer.

#++i% 4lain and F*T - vials

#++ii% (hemical balance #&herever necessary%

#++iii% FAIS- reader &ith printer, &asher and micropipettes.


33/60

#3% 'eagents for serological tests for syphilis and positive sera for controls.

#7% -nti Human lobulin Serum #(oombPs serum%

#0% Bovine -lbumin 33 percent Fn"yme reagents for incomplete antibodies.

#% FAIS- or '4H- test kits for Hepatitis and HI= I II.

#8% *etergent and other agents for cleaning laboratory glass&ares.

K. TESTING OF WHOLE BLOOD 8

# % It shall be responsibility of the licensee to ensure that the &hole blood

collected, processed and supplied conforms to the standards laid do&n in the

Indian 4harmacopoeia and other tests published, if any, by the overnment.

#3% ;reedom from HI= antibodies #-I*S% Tests !Fvery licensee shall get samples

of every blood unit tested, before use, for freedom from HI= I and HI= II

antibodies either from laboratories specified for the purpose by the (entral

overnment or in his o&n laboratory. The results of such testing shall be

recorded on the label of the container.

#7% Fach blood unit shall also be tested for freedom from Hepatitis B surface

antigen, and Hepatitis ( =irus antibody =*'A and malarial parasite and results

of such testing shall be recorded on the label of the container.


34/60

N$TFC

#a% Blood samples of donors in pilot tube and the blood samples of the

recipient shall be preserved for 9 days after issue.

#b% The blood intended for transfusion shall not be fro"en at any stage.

#c% Blood containers shall not come directly in contact &ith ice at any

stage.

L. RECORDS 8

The records &hich the licensee is required to maintain shall include inter alia

the follo&ing particulars, namelyC!

#% Blood donor recordC It shall indicate serial number, date of bleeding, name,

address and signature of donor &ith other particulars of age, &eight,

hemoglobin, blood grouping, blood pressure, medical e+amination, bag number

and patientPs detail for &hom donated in case of replacement donation,

category of donation #voluntary@replacement% and deferral records and

signature of :edical $fficer In!charge.

#3% :aster records for blood and its componentsC It shall indicate bag serial

number, date of collection, date of e+piry, quantity in ml. -B$@'h roup,

results for testing of HI= I and HI= II antibodies, :alaria, =.*.'.A., Hepatitis

B surface antigen and Hepatitis ( virus antibody and irregular antibodies #if

any%, name and address of the donor &ith particulars, utilisation issue number,

components prepared or discarded and signature of the :edical $fficerIncharge.

#7% Issue register C It shall indicate serial number, date and time of issue, bag

serial number, -B$@'h roup, total quantity in ml, name and address of the

recipient, group of recipient, unit@institution, details of cross!matching report,

indication for transfusion.

#0% 'ecords of components suppliedC quantity suppliedE compatibility report,

details of recipient and signature of issuing person.

#% 'ecords of -.(.*.@(.4.*@(4*!-@S-: bags giving details of manufacturer,

batch number, date of supply, and results of testing.

#8% 'egister for diagnostic kits and reagents usedC name of the kits@reagents,

details of batch number, date of e+piry and date of use.


35/60

#9% Blood bank must issue the cross matching report of the blood to the patient

together &ith the blood unit.

#>% Transfusion adverse reaction records.

#/% 'ecords of purchase, use and stock in hand of disposable needles, syringes,blood bags, shall be maintained.

N$TFC The above said records shall be kept by the licensee for a period of five years.

:. LABELS8

The labels on every bag containing blood and@or component shall contain the

follo&ing particulars, namelyC

#% The proper name of the product in a prominent place and in bold letters

on the bag.

#3% Name and address of the blood bank

#7% Aicence number

#0% Serial number

#% The date on &hich the blood is dra&n and the date of e+piry as

prescribed under Schedule 4 to these rules.

#8% - colored label shall be put on every bag containing blood. The

follo&ing color scheme for the said labels shall be used for different

groups of bloodCBlood roup (olor of the label

$ Blue

- ello&B 4ink

-B )hite

#9% The results of the tests for Hepatitis B surface antigen, and Hepatitis (

virus antibody, syphilis, freedom from HI= I and HI= II antibodies and

malarial parasite.

#>% The 'h group.#/% Total volume of blood, the preparation of blood, nature and percentage

of anti!coagulant.

#1% Leep continuously temperature at 3 degree centigrade to 8 degree

centigrade for &hole human blood and@or components as contained

under III of 4art


36/60

#% *isposable transfusion sets &ith filter shall be used in administration

equipment.

#3% -ppropriate compatible cross matched blood &ithout a typical antibody

in recipient shall be used.

G7% The contents of the bag shall not be used if there is any visible evidence

of deterioration ike haemolysis, clotting or discoloration.#0% The label shall indicate the appropriate donor classification like

=oluntary *onor or 'eplacement *onor in no less prominence than

the proper name.

N$TFSC

.ln the case of blood components, particulars of the blood from &hich such

components have been prepared shall be given against item numbers #%, #9%,

#>%, #/% and #0%.

3. The blood and@or its components shall be distributed on the prescription of a

'egistered :edical 4ractitioner .

II. BLOOD DONATION CAMPS.

- blood donation camp may be organi"ed by !

#a% a licensed designated 'egional Blood Transfusion (entreE or

#b% a licensed overnment blood bankE or

#c% the Indian 'ed (ross Society E or

#d%

a licenced blood bank run by registered voluntary or charitableorgani"ations recogni"ed by State or Qnion Territory Blood

Transfusion (ouncil.

N$TFC

#i% *esignated 'egional Blood Transfusion (entre shall be a centre

approved and designated by a Blood Transfusion (ouncil constituted

by a State overnment to collect, process and distribute blood and

its components to cater to the needs of the region and that centre has

also been licensed and approved by the Aicensing -uthority and

(entral Aicence -pproving -uthority for the purpose.#ii% The designated 'egional Blood Transfusion (entre. overnment

blood bank and Indian 'ed (ross Society shall intimate &ithin a

period of seven days, the venue &here blood camp &as held and

details of group &ise blood units collected in the said camp to the

licensing -uthority and (entral Aicence -pproving -uthority.


37/60

;or holding a blood donation camp, the follo&ing requirements shall be

fulfilled@complied &ith, namelyC!

:A; PREMISES, PERSONNEL ETC.

#a% 4remises under the blood donation camp shall have sufficient area andthe location shall be hygienic so as to allo& proper operation,

maintenance and cleaning.

#b% -ll information regarding the personnel &orking, equipment used and

facilities available at such a (amp shall be &ell documented and made

available for inspection, if required, and ensuringU

#i% continuous and uninterrupted electrical supply for equipment

used in the (ampE

#ii% adequate lighting for all the required activitiesE

#iii% hand!&ashing facilities for staffE

#iv% reliable communication system to the central office of the

(ontroller@$rganiser of the (ampE

#v% furniture and equipment arranged &ithin the available placeE

#v5% refreshment facilities for donors and staffE

#vii% facilities for medical e+amination of the donorsE

#viii% proper disposal of &aste.

#B% PERSONNEL FOR OUT-DOOR BLOOD DONATION CAMPC

To collect blood from 1 to 91 donors in about 7 hours or from 11 to 31donors in hours, the follo&ing requirements shall be fulfilled@complied

&ith C!

#i% $ne :edical $fficer and t&o nurses or phlebotomists for managing 8!>

donor tablesE

#ii% t&o medico social &orkersE

#iii% three blood bank techniciansE

#iv% t&o attendantsE

#v% vehicle having a capacity to seat >!1 persons, &ith provision for

carriage of donation goods including facilities to conduct a blooddonation camp.

:C; EQUIPMENTS 8

. B4 apparatus.

3. Stethoscope.


38/60

7. Blood bags #single, double, triple, quadruple%

0. *onor questionnaire.

. )eighing device for donors.

8. )eighing device for blood bags,

9. -rtery forceps, scissors.

>. Stripper for blood tubing./. Bed sheets, blankets@matress.

1. Aancets, s&ab stick@tooth picks.

. lass slides.

3. 4ortable Hb meter@copper sulphate.

7. Test tube #big% and 3+11 mm #small%

0. Test tube stand.

. -nti!-, -nti!B and -nti.-B, -ntisera and -nti!*

8. Test tube sealer film.

9. :edicated adhesive tape.

>. 4lastic &aste basket

/. *onor cards and refreshment for donors.

31.Fmergency medical kit

3.Insulated blood bag containers &ith provisions for storing bet&een 3

degree centigrade to 1 degree centigrade.

33.*ielectric sealer or portable sealer

37.Needle destroyer #&herever necessary%

I**. PROCESSING OF BLOOD COMPONENTS FROM WHOLE BLOOD

BY A BLOOD BANK

The Blood components shall be prepared by blood banks as a part of the Blood

Bank services. The conditions for grant or rene&al of licence to prepare blood

components shall be as follo&sC !:A; ACCOMMODATION 8

#% 'ooms &ith adequate area and other specifications, for preparing blood

components depending on quantum of &ork load shall be as specified in

item B under the heading I. BA$$* B-NLS@BA$$*

($:4$NFNTS of this 4art.

#3% 4reparation of Blood components shall be carried out only under closedsystem using single, double, triple or quadruple plastic bags e+cept for

preparation of 'ed Blood (ells (oncentrates, &here single bags may be

used &ith transfer bags.

:B; EQUIPMENT 8

#i% -ir conditionerE


39/60

#ii% Aaminar air flo& benchE

#iii% Suitable refrigerated centrifugeE

#iv% 4lasma e+presserE

#v% (lipper and clips and or dielectric sealerE

#vi% )eighing deviceE

#vii% *ry rubber balancing materialE#viii% -rtery forceps, scissorsE

#i+% 'efrigerator maintaining a temperature bet&een 3 degree centigrade to

8 degree centigrade, a digital dial thermometer &ith recording

thermograph and alarm device, &ith provision for continuous po&er

supplyE

#+% 4latelet agitator &ith incubator #&herever necessary%

#+i% *eep free"ers maintaining a temperature bet&een minus 71 degree

centigrade to minus 01 degree centigrade and minus 9 degree

centigrade to minus >1 degree centigradeE

#+ii% 'efrigerated )ater bath for 4lasma Tha&ingE

#+iii% Insulated blood bag containers &ith provisions for storing at

appropriate temperature for transport purposesC

:C; PERSONNEL8

The &hole time competent technical staff meant for processing of Blood

(omponents #that is :edical $fficer, Technical Supervisor, Blood

Bank Technician and 'egistered Nurse% shall be as specified in item (, under

the heading I. BA$$* B-NLS@BA$$* ($:4$NFNTS of this 4art.

:D; TFSTIN ;-(IAITIFSC

eneralC ;acilities for -,B, -B and $ groups and 'h#*% grouping.

HepatitisC B Surface antigen and Hepatitis ( virus antibody, =*'A, HI= I and

HI= II antibodies and malarial parasites shall be mandatory for every blood

unit before it is used for the preparation of blood components. The results of

such testing shall be indicated on the label.

:E; CATEGORIES OF BLOOD COMPONENTS8

#% CONCENTRATED HUMAN RED BLOOD CORPUSCLES8 The product

shall be kno&n as 4acked 'ed Blood (ells that is 4acked 'ed Blood (ellsremaining after separating plasma from human blood.

eneral 'equirements C

#a% StorageC Immediately after processing, the 4acked 'ed Blood (ells

shall be kept at a temperature maintained bet&een 3 degree centigrade to

8 degree centigrade.


40/60

#b% InspectionC The component shall be inspected immediately after

separation of the plasma, during storage and again at the time of issue.

The product shall not be issued if there is any abnormality in color or

physical appearance or any indication of microbial contamination.

#c% Suitability of *onorC The source blood for 4acked 'ed Blood (ells

shall be obtained from a donor &ho meets the criteria for Blood*onation as specified in item H under the heading I. BA$$*

B-NLS@BA$$* ($:4$NFNTS of this 4art.

#d% Testing of )hole BloodC Blood from &hich 4acked 'ed Blood (ells

are prepared shall be tested as specified in item L relating to Testing of

)hole Blood under the heading I.BA$$* B-NLS@BA$$*

($:4$NFNTS of this 4art.

#e% 4ilot samplesC 4ilot samples collected in integral tubing or in separate

pilot tubes shall meet the follo&ing specificationsC

#i% $ne or more pilot samples of either the original blood or of the

4acked 'ed Blood (ells being processed shall be preserved &ith

each unit of 4acked 'ed Blood (ells &hich is issued.

#ii% Before they are filled, all pilot sample tubes shall be marked or

identified so as to relate them to the donor of that unit or 4acked 'ed

Blood (ells.

#iii% Before the final container is filled or at the time the final product is

prepared, the pilot sample tubes accompanying a unit of 4acked 'ed

Blood (ells, shall be attached in a tamper!proof manner that shall

conspicuously identify removal and re!attachment.

#iv% -ll pilot sample tubes, accompanying a unit of packed red bloodcells, shall be filled immediately after the blood is collected or at the

time the final product is prepared, in each case, by the person &ho

performs the collection of preparation.

:F; PROCESSING 8

#i% SeparationC 4acked 'ed Blood (ells shall be separated from the &hole blood,!

#a% if the &hole blood is stored in -(* solution &ithin 3days, and

#b% if the &hole blood is stored in (4*-! solution, &ithin 7 days, from

the date of collection. 4acked 'ed Blood (ells may be prepared either by

centrifugation done in a manner that shall not tend to increase thetemperature of the blood or by normal undisturbed sedimentation

method. - portion of the plasma, sufficient to ensure optimal cell

preservation, shall be left &ith the 4acked 'ed Blood (ells.

#ii% 4acked 'ed Blood (ells ;ro"enC (ryophylactic substance may be added to the

4acked 'ed Blood (ells for e+tended manufacturerPs storage not &armer than


41/60

minus 8 degree centigrade provided the manufacturer submits data to the

satisfaction of the Aicensing -uthority and (entral Aicence -pproving

-uthority, as adequately demonstrating through in!vivo cells survival and other

appropriate tests that the addition of the substance, the material used and the

processing methods results in a final product meets the required standards of

safety, purity and potency for 4acked 'ed Blood (ells, and that the fro"enproduct shall maintain those properties for the specified e+piry period.

#iii% TestingC 4acked 'ed Blood (ells shall conform to the standards as laid do&n

in the Indian 4harmacopoeia.

:2; PLATELETS CONCENTRATES8

The product shall be kno&n as 4latelets (oncentrates that is platelets

collected from one unit of blood and re!suspended in an appropriate volume of

original plasma.

eneral 'equirements C

#i% SourceC

The source material for platelets shall be platelet!rich plasma or buffy

coat &hich may be obtained from the &hole blood or by plateletpheresis.

#ii% 4rocessingC

#a% Separation of buffy!coat or platelet!rich plasma and platelets and re!

suspension of the platelets shall be in a closed system by!centrifugal

method &ith appropriate speed, force and time.

#b% Immediately after collection, the &hole blood or plasma shall be held

in storage bet&een 31 degree centigrade to 30 degree centigrade. )henit is to be transported from the venue of blood collection to the

processing laboratory, during such transport action, the temperature as

close as possible to a range bet&een 31 degree centigrade to 30 degree

centigrade shall be ensured. The platelet concentrates shall be separated

&ithin 8 hours after the time of collection of the unit of &hole blood or

plasma.

#c% The time and speed of centrifugation shall be demonstrated to produce

an unclamped product, &ithout visible haemolysis, that yields a count

of not less than 7.+11 #7.+1 raised to the po&er of 1% and

0.+11#0.+1 raised to the po&er ten% i.e. platelets per unit from aunit of 71 ml and 01 ml blood respectively. $ne percent of total

platelets prepared shall be tested of &hich 9 percent of the units shall

conform to the above said platelet count.

#d% The volume of original plasma used for re!suspension of the platelets

shall be determined by the maintenance of the pH of not less than 8

during the storage period. The pH shall be measured on a sample of


42/60

platelets &hich has been stored for the permissible ma+imum e+piry

period at 31 degree centigrade to 30 degree centigrade.

#d% ;inal containers used for platelets shall be colorless and transparent to

permit visual inspection of the contents. The caps selected shall

maintain a hermetic seal to prevent contamination of the contents. The

container material shall not interact &ith the contents, under the normalconditions of the storage and use, in such a manner as to have an

adverse effect upon the safety, purity, potency, or efficacy of the

product. -t the time of filling, the final container shall be marked or

identified by number so as to relate it to the donor.

#iii% StorageC

Immediately after re!suspension, platelets shall be placed in storage not

e+ceeding for a period days, bet&een 31 degree centigrade to 30

degree centigrade, &ith continuous gentleagitation of the platelet

concentrates maintained throughout such storage.

#iv% TestingC

The units prepared from different donors shall be tested at the end of the

storage period for !

#a% 4latelet countE

#b% pH of not less than 8 measured at the storage temperature of the

unitE

#c% measurement of actual plasma volumeE

#d% one percent of the total platelets prepared shall be tested for sterilityE

#e% the tests for functional viability of the platelets shall be done by

s&irling movement before issueE#f% if the results of the testing indicate that the product does not meet

the specified requirements, immediate corrective action shall be

taken and records maintained.

#iv% (ompatibility TestC

(ompatible transfusion for the purpose of variable number of 'ed

Blood (ells, -, B, -B and $ grouping shall be done if the platelets

concentrate is contaminated &ith red blood cells.

:=; GRANULOCYTE CONCERNTRATES8

#i% StorageC It shall be kept bet&een 31 degree centigrade to 30 degreecentigrade for a ma+imum period of 30 hours.

#ii% Qnit of granulocytes shall not be less than +11 #i.e. +1 raised

to the po&er of 1% &hen prepared on cell separator.

#iii% roup specific tests@HA- test &herever required shall be carried out.

:>; FRESH FRO?EN PLASMA8


43/60

4lasma fro"en &ithin 8 hours after blood collection and stored at a temperature

not &armer than minus 71 degree centigrade, shall be preserved for a period of

not more than one year.

:@; CRYOPRECIPITATE8

(oncentrate of anti!hemophiliac factor shall be prepared by tha&ing of thefresh plasma fro"en stored at minus 71 degree centigrade.

#a% StorageC

(ryoprecipitate shall be preserved at a temperature not higher than minus 71

degree centigrade and may be preserved for a period of not more than one

year from the date of collection.

#b% -ctivityC

-nti!hemophiliac factor activity in the final product shall be not less than >1

units per bag. $ne percent of the total cryoprecipitate prepared shall be

tested of &hich seventy five percent of the unit shall conform to the said

specification.

:3; PLASMAPHERESIS, PLATELETPHERESIS, LEUCAPHERESIS

USING A CELL SEPARATOR.

-n area of 1 square meters shall be provided for apheresis in the blood Bank.

The blood banks specifically permitted to undertake the said apheresis on the

donor shall observe the criteria as specified in item H relating to (riteria for

blood donation under the heading I. Blood Banks@Blood (omponents of this4art. The &ritten consent of the donor shall be taken and the donor must be

e+plained, the ha"ards of apheresis. The :edical $fficer shall certify that donor

is fit for apheresis and it shall be carried out by a trained person under

supervision of the :edical $fficer.

:A; PLASMAPHERESIS, PLATELET PHERESIS AND

LEUCAPHERESIS8

The donors sub5ected to plasmapheresis, plateletpheresis and leucopheresis

shall, 5n addition to the criteria specified in item H relating to the ('ITF'I-

;$' BA$$* *$N-TI$N, under the heading I. BA$$* B-NLS@ BA$$*($:4$NFNTS of this 4art being observed, be also sub5ected to protein

estimation on post!pheresis@ first sitting &hose results shall be taken as a

reference for subsequent 4heresis@Sitting. It shall also be necessary that the

total plasma obtained from such donor and periodicity of 4lasmapheresis shall

be according to the standards described under validated Standard $perating

4rocedures.


44/60

N$TFC

#i% -t least 0> hours must elapse bet&een successive apheresis and not

more than t&ice in a &eek.

#ii% F+tracoporeal blood volume shall not e+ceed V of donorPs

estimated blood =olume.

#iii% 4latelet pheresis shall not be carried out on donors &ho have takenmedication containing -sprin &ithin 7 days prior to donation.

#iv% If during plateletpheresis or leucapheresis, 'B(s cannot be re!

transfused then at least 3 &eeks shall elapse before a second

cytapheresis procedure is conducted.

:B; MONITORING FOR APHERESIS8

Before starting apheresis procedure. hemoglobin or haematocrit shall be done.

4latelet count, )B( counts, differential count may be carried out. In repeated

plasmapheresis, the serum protein shall be 8 gm @11 ml.

:C; COLLECTION OF PLASMA8

The quantity of plasma separated from the blood of a donor shall not e+ceed

11 ml per sitting and once in a fortnight or shall not e+ceed 111 ml per

month.

PART XII C

I. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS

The blood products shall be manufactured in a separate premises other than that

meant for blood bank. The requirements that are essential for grant or rene&al of

licence to manufacture blood products such as -lbumin, 4lasma 4rotein ;raction,

Immunoglobins and (oagulation ;actor (oncentrates, shall be as follo&s,

namelyC!

A. GENERAL REQUIREMENTS

. Aocation and surroundings, buildings and &ater supplyC

The requirements as regards location and surrounding, buildings and &ater

supply as contained in paragraphs .., ..3, ..7 of 4art I of Schedule :shall apply mutatis mutandis to the manufacture of blood products.

3. *isposal of &aste and infectious materialsC

#i% The requirement as regards disposal of &aste and infectious materials

as contained in paragraph ..0 of 4art I of Schedule : shall apply

mutatis mutandis to the manufacture of blood products.


45/60

#ii% 4roper facility shall also be provided for potentially infectious

materials, particularly HI= I HI= II, Hepatitis B #surface antigen and

Hepatitis ( virus antibody% through autoclaving, incineration or any

other suitable validated methods.

7. Health, clothing and sanitation of personnelC

#i% The requirement as contained in paragraph 7 of 4art I of Schedule :shall be complied &ith.

#ii% The personnel &orking in the manufacturing areas shall be vaccinated

against Hepatitis B virus and other infectious transmitting diseases.

0. 'equirements for manufacturing area for Blood 4roductsC

#i% ;or the manufacture of blood products, separate enclosed areas

specifically designed for the purpose shall be provided. These areas be

provided &ith air locks for entry and shall be essentially dust free and

ventilated &ith an air supply. -ir supply for manufacturing area shall be

filtered through bacteria retaining filters #HF4- ;ilters% and shall be at a

pressure higher than in the ad5acent areas.

The filters shall be checked for performance on installation and

periodically thereafter, and records thereof shall be maintained.

#ii% Interior surfaces #&alls, floors and ceilings% shall be smooth and free

from cracks, they shall not shed matter and shall permit easy cleaning

and disinfection. *rains shall be e+cluded from aseptic areas.

'outine microbial counts of the manufacturing area shall be carried out

during manufacturing operations. The results of such counts shall be

checked against &ell documented in!house standards and records

maintained.-ccess to the manufacturing areas shall be restricted to a minimum

number of authorised personnel. Special procedures for entering and

leaving of the manufacturing areas shall be prominently displayed.

#iii% Sinks shall be e+cluded from aseptic areas. -ny sink installed in other

clean areas shall be of suitable material such as stainless steel, &ithout

an overflo&, and be supplied &ith &ater of potable quality. -dequate

precautions shall be taken to avoid contamination of the drainage system

&ith dangerous effluents and airborne dissemination of pathogenic

micro!organisms.

#iv% Aighting, air!conditioning, ventilation shall be designed to maintain asatisfactory temperature and relative humidity to minimise

contamination and to take account of the comfort of personnels &orking

&ith protective clothing.

#v% 4remises used for the manufacture of blood products shall be suitably

designed and constructed to facilitate good sanitation.


46/60

#vi 4remises shall be carefully maintained and it shall be ensured that

repair and maintenance operations do not present any ha"ard to the

quality of products. 4remises shall be cleaned and, &hereapplicable,

disinfected according to detailed &ritten validated procedures.

#vii% -dequate facilities and equipments shall be used for the manufacture

of blood products derived from blood plasma.#viii% -ll containers of blood products, regardless of the stage of

manufacture, shall be identified by securely attached labels. (ross

contamination shall be prevented by adoption of the follo&ing measures,

namely C!

#a% processing and filling shall be in segregated A areas E

#b% manufacture of different products at the same time shall be

avoidedE

#c% simultaneous filling of the different products shall be avoidedE

#d% ensure transfer, containers@materials by means of airlocks, air

e+traction, clothing change and careful &ashing and

decontamination of equipmentE

#e% protecting containers@materials against the risk of contamination

caused by re!circulation of untreated air or by accidental re!entry

of e+tracted airE

#f% using containers that are sterilised or are of documented lo&

bioburden.

#i+% 4ositive pressure area shall be dedicated to the processing area

concernedE

#+% -ir!handling units shall be dedicated to the processing area concernedE

#+i% 4ipe &ork, valves and vent filters shall be properly designed to

facilitate cleaning and sterlisation. =alves on fractionation @ reacting

vessels shall be completely steam!sterlisable. -ir vent filters shall be

hydrophobic and shall be validated for their designated useE

. -ncillary -reasC

#i% 'est and refreshment rooms shall be separated from other areas.

#ii% ;acilities for changing and storing clothes and for &ashing and toilet

purposes shall be easily accessible and appropriate for the number of

users. Toilets shall not be connected directly &ith production or storageareas.

#iii% :aintenance &orkshops shall be separated from production areas.

)herever parts and tools are stored in the production area, they shall be

kept in rooms or lockers reserved for that use.

#iv% -nimal houses shall be &ell isolated from other areas, &ith separate

entrance.


47/60

B. COLLECTION AND STORAGE OF PLASMA FOR FRACTIONATION8

#a% (ollection C

#% 4lasma shall be collected from the licensed Blood Banks through

a cold chain process and stored in fro"en condition not &armer

than minus t&enty degree centigradeE#3% Individual plasma shall remain in quarantine till it is tested for

Hepatitis B surface antigen and Hepatitis ( virus antibody HI= I

and HI= II.

#7% - sample from pooled !lot plasma of about 1!3 units of

different donors shall be tested for Hepatitis B surface antigen and

Hepatitis ( virus antibody, HI= I and HI= II and if the sample

found negative, only then it shall be taken up for fractionation.

#b% Storage -rea C

#% Storage areas shall be of sufficient space and capacity to allo&

orderly storage of the various categories of materials,

intermediates, bulk and finished products, products in quarantine,

released, re5ected, returned, or recalled products.

#3% Storage areas shall be designed or adopted to ensure good

storage conditions. In particular, they shall be clean, dry and

maintained &ithin temperature required for such storage and

&here special storag

guidelines for blood bank

Documents