Presented by :-

Mr. Shankar S.Yelmame

M.Pharm 1st yr (QAT)

Amrutvahini College of pharmacy,

Sangamner

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Introduction

Objective & importance

Principles of material management

Functions of material management

Purchasing

Vendor development

Types of Materials

References

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DefinitionIt is an organizational concept, which has theauthority & responsibility of all activities,principally concerned with the flow of materials inthe organization.

OR

The International Federation of Purchasing andMaterials Management accept the definition ofmaterials management given below.

“According to it, materials management is a totalconcept having its definite organization to plan andcontrol all types of materials, its supply, and its flowfrom raw stage to finished stage so as to deliver theproduct to customer as per his requirements in time."

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The prime objective of the pharmaceutical

manufacturing operations is-to produce finished

pharmaceutical pdts from active, inactive raw

materials and various packaging material.

The quality of finished products is depend upon

the quality inputs - hence material management is

very important.

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Primary

(i) Efficient materials

planning

(ii) Buying or Purchasing

(iii) Procuring and receiving

(iv) Storing and inventory

control

(v) Supply and distribution

of materials

(vi) Quality assurance

(vii) Good supplier and

customer relationship

(viii) Improved departmental

efficiency

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Secondary

(i) Efficient production scheduling

(ii) To take make or buy decisions

(iii) Prepare specifications and standardization of materials

(iv) To assist in product design and development

(v) Forecasting demand and quantity of materials

requirements

(vi) Quality control of materials purchased

(vii) Material handling

(viii) Use of value analysis and value engineering

(ix) Developing skills of workers in materials management

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To procure right materials

-In Right Quantity

-Of Right Quality

-At Right Time

-From Right sources

-At Right prices

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Centralized :- the purchasingprocedure of materials fordifferent department is donetogether from onepurchasing department. Thisis seen in smallorganizations.

Advantages

Efficient system

Bargaining capabilitiesincreased

Good raw material obtainedat lower price

Decentralized:- differentdepartment purchasetheir requirementseparately. This isbasically seen in largeorganizations.

Advantages

Flexible purchasingsystem

Procurement is faster

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Vendor is a person who sells & supplies his products.

An intelligent purchasing process involves the rationalselection of sources from which materials can beobtained. Considerable efforts are needed inidentifying, developing & evaluating the prospectivesuppliers.

Factors to be considered in developing a vendor –

- Quantity required to be purchased.

- Time available for making such purchases.

- If the material be required repeatedly or occasionally.

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Volume of the purchase of required materials.

Industry producing the required materials.

Commercial viability of the materials.

For the purchase of items that are of repetitive

nature, a detailed evaluation procedure of

suppliers is adopted

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Need recognitionSpell out of specifications &

requirements

Official requisitions

Check specifications,

prices/supplies

Select suppliers

Purchase order for supply

Suppliers’ acceptance

Specifications

filePurchase

records

Supplier’s

recordEnquiry tender

Follow-up

Quotations & analysis prices and terms, negotiations,

finalization

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Delivery of materials

Materials & reports, analysis

Payment made

Checking of invoice

with purchase order

Cont…

The various types of materials to be managed are:

(i) Purchased materials: They are raw materials, packaging materials

(ii) Work in process (WIP) materials: These are semi-finished and finished parts and components lying on the shop floor.

(iii) Finished goods: These are the final products either waiting to be assembled in the assembly lines or in stores which are stocked for final delivery waiting to sell.

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Supplier’s name –in companies approved vendor

list.

all RM should be checked for-

a) Name of supplier

b) Name of the product

c) Batch numbers

d) Date of mfg and expiry

e) Qty received & no. of containers

f) Condition of containers and materials

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All containers should be clean externally-if anydamage-informed to QC Dept.

Should be protected from contamination duringstorage.

The materials received should be taken into accountonly after all the relevant documents are available-(e.g.bills,invoice,customs or excise gate passes,certificateof analysis etc.)

Sampling in specific sampling booths by Q.C. personand stored in sampled material quarantine.

Materials in the storage area should be appropriatelylabelled. label should bear –

a) Name & internal code no. of the product

b) Batch no. given by supplier and also given byreceiver after analysis & release

c) Status of material

d) Retest & expiry date of the product

e) Appropriate special storage conditions

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Materials should be dispensed only by designatedpersons, following written procedure ,to ensure that thecorrect materials are accurately weighed or measuredinto clean and properly labelled container

a) Correct name & category(IP/BP/USP)

b) Correct wt.

c) Batch no. of the product

All dispensed materials must be recorded in a registerin chronological order of date and time.The recordshould have –

a) Name of pdt & batch no.

b) Time and date of starting and completion of thedispensing activity

c) Name of weigher and checker of the dispensedmaterials.

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1) Primary packaging materials:Materials which

come in direct contact with the medicinal product.

e.g.bottles,ampoules,vials,foils etc

2) Secondary packaging materials: Materials

which come in direct contact with the primary

packaging materials. e.g.labels,carton etc.

3) Printed packaging materials: all PM which have

any thing printed on it;even error medical literature sent

along with finished pdt is also put in this category.

e.g.labels, cartons,foils etc.

4) Tertiary & other packaging materials: All other

PM other than those covered in the above three

categories.

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Intermediate & bulk product may be defined as the material , which has started processing but not yet got converted into the finished saleable product.

Intermediate & bulk product storage is the responsibility of the production dept.

Examples.

Granulated materials ready for compression

Compressed tablets for coating or packaging.

Filtered or unfiltered liquids for oral or injectables.

These pdts should be kept under appropriate storage condition of temp, relative humidity, class of air etc.

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Finished products are products which are in

marketable pack.

Should be held in quarantine until their final

release, after which they should be stored.

Each batch should be tested against its

specifications and then released for distribution or

sale.

Products faiing to meet the established

specifications should be rejected.

Reprocessing may be performed,if feasible,but the

reprocessed product should meet all specifications.

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Materials at any stage, which have been tested

against a set of predefined specification and found

not meeting the specifications fully. We can deal

with such material mainly in two ways:

a) Reprocess and retest the materials to see whether

it meets our specific requirements

b) Destroy or send it to the supplier.

Clearly marked as such and stored separately in

restricted areas.Such areas in industry are normally

painted red in colour.

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Products which are already distributed or sold,

may be required at times to be recalled from

market for various reasons .e.g. substandard

quality detected after the product was distributed,

damage of goods during transit.

Such recalled products should be clearly identified

and stored separately in a secure area until a

decision is taken on their fate.

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Pharmaceutical products can be returned from

market for various reasons. e.g.quality problems,

accidental damage of goods etc.

physically examine the condition of the goods

returned.

Ask Q.C. dept. to evaluate the quality.

If it is possible to reprocess and recover-may

considered for relabelling, repacking & resaling

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Reagents made up in the lab should be prepared according to written procedures and appropriately labelled.such labels should indicate following information.

a) Name of the reagent

b) Nominal concentration

c) Standardisation factor

d) Shelf life

e) Date when re-standardisation is required.

f) The storage conditions.

g) Name/signature and date of the person who has prepared and standardised the reagent.

A register be maintained giving details of the reagents made,standardised,restandardised & used and destroyed if any.

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Pharmaceutical manufacturing operations generate lot of waste materials. These materials can be classified in two categories:

a) Trash : which do not have any resale value and may be disposed off by proper method depending upon the nature of the trash.

b) Scrap : which do have a resale value and may be sold to scrap dealers,after proper segregation.

Before disposal of these materials,they can be segregated in different categories:

1) Paper

2) Aluminium foils

3) Plastic

4) Glass

5) Metallic containers.

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May be available in the form of official reference standards.

Reference std. prepared by the producer should be tested, released and then stored in the same way as official standards.

They should be kept under the responsibility of a designated person in a secure area.

Rodenticides, insecticides, fumigating agents and sanitising materials fall under this category, these materials should not be permitted to contaminate equipment, raw materials, packaging materials, in-process materials or finished products.

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It reduces considerably the idle time of the workers.

The quality of the materials is also maintained

through minimum human touches, elimination of

breakages, etc.

Every inch of the factory space is properly utilized.

It helps in maintaining effective production

planning and control.

Reduced operating costs and timely production.

Greater job satisfaction on the part of both the

workers and the employer.

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1. Pharmaceutical Quality Assurance by Manohar

A.Potdar , Nirali Prakashan, page no. 4.1-4.18

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