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Pharmaceutics 2 (PMC2)

BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00

Course Orientation,House Rules and Pre-laboratory discussion

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BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00

Course OrientationSyllabus

Requirements

House RulesLaboratory Rules

AO 55 s.1988:Requirements for Labelling Materials of Pharmaceuticals

AO 109 s.1969Prescription DrugLabel Symbol

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Course Orientation

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Course ObjectiveAt the end of the course the students should be able to:1. Cognitive: Practice and apply the principles of the GxP’s, with particular emphasis onGDP, GMP, GPP in the production of pharmaceuticals, cosmetics andveterinary products.

2. Psychomotor:Dispense, manufacture, label and package a pharmaceutical, cosmetic, andveterinary product, in adherence and compliance to GxP’s.

3. Affective:Appreciate the pharmacist’s social professional responsibilities in helpingrestore or maintain the health of men and animals and of the high moraland ethical standards that are required of the pharmacy profession.

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Manufacture of Drugs, Cosmetics and Veterinary Medicine

5 unit subject: 3 lecture, 2 laboratory

The course familiarizes the students with the concept ofcGMP involved in pharmaceutical manufacture. Acquisitionof the basic knowledge in the regulatory and technicalrequirements of the Food and Drugs Administration in theproduction of Drugs, Cosmetics and Veterinary products.

PRE-REQUISITE:Pharm.5 – Biopharmaceutics and Pharmacokinetics

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Requirements:During preparation day:

1. Complete PPI2. Task tag

To be passed after each preparation day30mins. before end of session(10) 1. One (1) fully accomplished answer sheet per group(45) 2. Preparation*** 3. Index card

To be passed on the 2nd meeting before the final examination (1st period of session):

1. An advertisement in a form of a commercial.30 second commercial for 5 preparations (2min 30sec)

(any preparation)(CD burned)

2. A portfolio of your preparations.

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Criteria for preparations:Each preparation is equivalent to 50 points.

Part 1: Secondary packagingDesign - 3Readability - 2Adherence to AO 55 and AO 109 - 5 *Capability to carry primary container - 3 *

Part 2: Primary packagingDesign - 3Readability - 2Adherence to AO 55 and AO 109 - 5 *Appropriateness of container - 5 *

Part 3: Content(depends on preparation) - 15

Part 4: Package insertReadability - 2Content - 5

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Class ParticipationEach laboratory session day:Attendance: (grace period of 15 min. PST)

Present: 2 pts.Late: 0.5 pt. (up to 30 min. only)Absent: 0 pt.

*in final computation of grade, an excess of 0.5 is not rounded off to 1

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Class ParticipationEach laboratory session day:Deduction guide:

No/improper use of head cap: - 2No/improper use of face mask: - 2

* No gloves: - 2No shoe cap: - 1With jewellery/nail polish/facial hair - 1/ part/pcNo/improper use of lab gown: - no experimentNo task tag - 1

*Sitting while course of experiment - 2Cluttered worktable - 5

*not applicable to labellerDeduction procedure:

1. Random inspection2. Deduction to members = Deduction to inspector3. Deduction to inspector = Deduction to inspector4. Above guide is to be applied on the total score

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Class ParticipationEach preparation day:Deduction guide:

Late submission - 5 per 10mins.

Deduction procedure:1. Submission is 30 min. before end of session.2. Deduction applies to the total grade on preparation

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Class ParticipationEach preparation day:Maximum total possible score:

Preparation: 50 pts.Answer sheet: 10 pts.Attendance: 2 pts. .

62 pts.

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Reminders:20% absences, consecutive or non-consecutive:

automatic unofficially drop.

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Criteria for project50 points

10 Originality20 Adherence to current laws governing advertisement of

pharmaceutical products20 Content

*late submission deduction guide applies

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Materials needed/groupTissue / lint-free tissueMantleMasking tapePermanent markerDishwashing liquid/hand soapRagsSando bag

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BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00


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BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00


Requirements




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House Rules

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Course Orientation

Complete PPIBefore Session:

1. Anteroom2. Proper hand washing

During Session:1. No sitting2. Maintain cleanliness of workplaceProcess: Inspector with all members:

a. Dispensing/Weighingb. Compoundingc. Labelling

** inspector must make sure to supervise all task. Follow laboratory manual.After session policy

1. CLAYGOPre-laboratory discussion:

1st meeting per weekMeasurements and preparation for manufacturing order

1st meeting per weekPost-laboratory discussion:

Week before examination*Expect 2 M.O. per preparation day.

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©to respective owner NCII©to respective owner NCII

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BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00


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BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00


Requirements




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AO 55 s.1988:Requirements for

Labelling Materials of Pharmaceuticals

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Requirements for labelling

materials of pharmaceutical

products

Formulated by DOH with accordance to

RA 3720 with amendments from EO 175

and RA 6675

Requirements for labelling materials of pharmaceutical products

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Label on immediate container, and other printed materials that are incorporated with the product

at the time of purchase.

E.g. Wrapper cartons, leaflet/package insert.


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refers to pharmaceutical products, which mean any pharmaceutical or biological intended to be

used in the Dx, cure, mitigation and Tx or prevention of dse

in human or affect the structure or any fx of the .

human body. .


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proprietary or trade name assigned to the product by the drug establishment


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refers to the identification of drugs and medicines by their scientifically and

internationally recognized active ingredients determined by the FDA of the DOH


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classification of the product based on the Tx action as specified in the product registration


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refers to the name(s) and amount(s) of active medicinal ingredients per dosage unit

expressed in the METRIC system


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the approved clinical use of the product based on substantial and scientifically supported

evidence of the safety and efficacy of the drug in the given dosage form


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pharmaceutical form of the preparation based on the official pharmacopoeia


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the site and manner the product is to be introduced in or applied on the body


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statements regarding the occurrence of potential hazards and side effects associated with use of

the product and the limitation of its use


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instruction and special care required in the use of the product to avoid undesired effects and to

ensure the safe and effective use of the drug


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products other than biological products means the date, in month and year, during which

processing of the bulk product, from which goods are to be filled, is completed


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refers to any distinctive combination of letters and/or numbers, assigned to a particular batch produced during a given cycle of manufacture.

It permits production history of the batch including all stages of manufacture and control, to be traced and reviewed.


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distinctive combinations of letters and/or numbers assigned to a particular lot,

defined as a portion of the batch


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date after which the product is not expected to retain its claimed safety, efficacy and quality or

potency or after which it is not permissible to sell, distribute or use said product.


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total amount/quantity/number of dosage form in a certain container of the product expressed in

metric system


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refers to prevailing specified range temperature, humidity and other environmental factors within optimal stability of the product is ensured based

on laboratory data


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part of the label that is most likely to be displayed, presented, shown or examined under

customary condition of display for retail use


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area or surface of the container/package where the display panel is located


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first pack containing the individually wrapped products,

strip blister packs


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1. Name of the product

(GN alone or with BN, as the case may be)

2. Dosage Form and strength

3. Pharmacologic Category

4. Rx symbol, in case of prescription drug

5. Name and complete address of manufacturer

6. Net Content

7. Formulation

8. Indication

9. Contraindication/s, Precaution/s, Warning/s

10. Mode of administration or Directions for use

11. Batch and Lot number

12. Exp. date and date of Mfg.

13. Registration number

14. Storage conditions

15. For Rx drugs:

FOODS, DRUGS, DEVICES AND COSMETIC ACT

PROHIBITS DISPENSING WITHOUT PRESCRIPTION


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•Must be in English or Filipino

• It should be Clearly and Prominently Displayed

•Readable with normal vision without straining

•Color contrast, position and spacing of the information must be taken into consideration in complying with the reqmt’s

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PRINCIPAL

D I S P L A Y

P A N E L

Contain the following:1. Name of the product

(GN alone or with BN, as the case may be)

2. Dosage Form and strength

3. Pharmacologic Category

4. Rx symbol, in case of prescription drug

5. Name & complete address of manufacturer

6. Net ContentMUST…

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PRINCIPAL

D I S P L A Y

P A N E L

Comprise 40% of the total surface of thecontainer, except in the case of therectangular container where the totalarea of the principal display panel mustequal to the product of the height andwidth of the entire side of the container.

For any other shaped containerpresenting an obvious principal displaypanel such as the top of a triangular orcircular container, the size of the areashall consist of the entire top surface.

MUST…

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IMMEDIATECONTAINER

O U T S I D E

O F T H E

PRINCIPAL

D I S P L A Y

P A N E L

MUST CONTAIN THE FOLLOWING1. Formulation2. Indication (s)3. Mode of Administration(s)

and the Direction(s) for use4. Batch and Lot number5. Expiry/Expiration date of manufacture6. Registration number7. Storage Conditions8. Rx notice for Rx drugs:FOODS, DRUGS, AND DEVICES AND

COSMETIC ACT PROHIBITS DISPENSINGWITHOUT PRESCRIPTION

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These informations shall appear on the other labelling materials such as inserts or leaflets or wrapper cartons.


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GENERIC NAME

IN ALL CASES, THE GENERIC NAME shall be the

prominently printed element on the label,

It is defined as the one with the highest point size among various printed elements on the label.

It shall be enclosed exclusively by an outline box rendered in the same color as the generic name

Brand Name of Some DrugSpecific requirements for the name of the product in

labelling drug products

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GENERIC NAME

The background color inside the box, against the GN is rendered,

should be the same color as the background color outside the box,

against which the BN is rendered



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GENERIC NAME salt form

IN ALL CASES, the GN shall be printed in full,NOT abbreviated and in accordance with the

International Non-proprietary Name (INN).

In cases the salt or specific chemical form of the drug needs to be indicated, this must be included inside the but

in smaller font size



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GN and BN shall be of the same typeface, font and color

GN shall appear immediately above the brand name and rendered in a point size bigger than the brand name



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GENERIC NAMEsalt form

If the BN is presented with a special typeface exclusively designed and used for it.

The GN shall be rendered in HELVETICA MEDIUM orUNIVERSE MEDIUM be rendered while complying with

the pertinent provisions presented earlier.

Brand NameSpecific requirements for the name of the product in


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Active1 Active2

For products containing TWO (2) active ingredients:The GN of both active ingredients indicated within the box

for generic name.



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Active1 Active2

For products containing THREE or MORE active ingredients:An official name for the combination,

which shall serve as the equivalent generic name,Shall be designated by a FDA committee of experts.

Starting date at which the official name can be used shall be determined by FDA.



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Dosage form shall be specified as:TABLETS, CAPSULES, SYRUPS, SUSPENSIONS,

OINTMENTS, including special delivery system such as SUSTAINED-RELEASE, etc.

Brand Name of Some DrugTABLET

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Shall conform to the category used in the PNDF.

Drugs that cannot be classified under the said categories may be given a Tx category other than what appears in

annex “A” of AO55 s.1988subject to the approval of FDA taking into consideration

current acceptable standards for Tx categories.


ANTIPYRETIC

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It must be printed in contrasting color to the background on which it appears.

Overprinting or superimposition of the Rx symbol is allowed PROVIDED that such will not result in obliterating

or rendering less legible the other required label requirements.

The Rx symbol should be printed in a type size no less than 1/5 of the height of the principal display panel.


ANTIPYRETICRx

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Complete name and address of manufacturer and also trader, when applicable, must appear on the principal

display panel.


ANTIPYRETICRxManufactured and distributed by:Prime Laboratories IncorporatedKm.44 Malolos City, Philippines

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Net content shall indicate the total amount/quantity/number of the dosage form in a given

container of the product expressed in metric system



60mL

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Active ingredients must be stated in their generic names (INN).

The amounts of the active ingredients shall be expressed in the metric system/unit of potency.

Salt or chemical forms must be stated, when applicable.



60mLFormulation:Brand name of Some Drug contains:Generic Name……… 50mg

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Multiple components must be enumerated in decreasing pharmacologic activity.

The coloring agent and other excipients used in the formulation that may cause hypersensitivity/ADR must be

indicated.

Alcohol content must be expressed in percent.




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shall only be the approved clinical use of the product

Based on approved FDA registration




Indication:For patients with……

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Full information regarding contraindications to the use of the product as well as precautions are to be observed in its

administration and use must be provided.





Contraindicated to…

Warning:

Precaution:

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Warning statements as required and specified by FDA must be provided.






Warning:

Precaution:

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In some cases, FDA may prescribe certain labelling information to be indicated on the label of certain drug

product.






Warning:

Precaution:

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Informations about the recommended dosage, including initial dose, usual dose, freq. interval,

duration of Tx, dosage adjustment or other pertinent aspects of drug Tx must be given in full



60mLMode of administration:

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Dilution, reconstitution, preparation and administration must be provided.

Separate directions for adults and children must be stated, and if not recommended for children, the dosage shall be

clearly identified as “adult dose”.





Dose:

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If the entire batch is MARKETED UNDER ONE COMPANY,ONLY THE BATCH NUMBER needs to be indicated.

If batch is divided into several lots are MARKETED BY DIFFERENT COMPANIES,

the LOT NUMBER and its CORRESPONDING BATCH NUMBER shall be indicated in every lot.





Dose:

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Batch and/or Lot number must be printed on each strip of ten (10) blister units.





Dose:

BATCH: PLI1-1115-93

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The expiry date shall be expressed in terms of the month and the year. In such cases, the last day of the month is

assumed as the expiration date.

For a drug that is reconstituted prior to use, a period of guaranteed efficacy must be specified at a given storage

condition.





Dose:

BATCH: PLI1-1115-93

EXP: 11/15

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The EXP date shall be printed or embossed on the tin foil, blister and/or strip package.





Dose:

BATCH: PLI1-1115-93

EXP: 11/15

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Reg. no. shall indicate the drug registration number and code assigned by FDA





Dose:

BATCH: PLI1-1115-93

Reg: EWDF81238EXP: 11/15

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Storage conditions appropriate for the product must be stated





Dose:

BATCH: PLI1-1115-93

Reg: EWDF81238EXP: 11/15

Store in cool dry place.

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In addition to requirements stated earlier:

The name and proportion of any antimicrobial agent in the product

Name any adjuvant in the product or any substance which, when administered with an antigen, modifies immune response to that antigen.

Name of species of animal or organism from which the product has been prepared.

For monoclonal antisera, the name of sp. Source or name of sp. of origin of hybridoma cell line used in the prep. of the product.

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For viral vac. Produced in animal cells or cell cultures, the name of the cell culture substrate, or the name of the species of animal and tissue used in the manufacture of the product, as well as the name of any residual antibiotic present in the product when applicable.

Potency of biological products which needs to be prepared before use.

Potency unit shall be the International Unit, approved by the FDA taking into consideration current acceptable standards.

Date of manufacture pertaining to month and year.

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Name and quantity of all excipients in the product except for large volume injections.

Statement of recommended routes of administration.

If antimicrobial agent is not present in the product, the words “USE ONLY ONCE or DISCARD ANY REMAINING PORTION” or words to that effect.

Where the contents of the container are to be used in one occasion only, the words “SINGLE USE” or “SINGLE DOSE” must be present.

For conc. solution for injection, a direction not to administer the solution undiluted and directions for dilution must be present

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Name and quantities of all excipients and AI in the nominal volume of fluid in the container, listing in descending order of magnitude.

If there is an amino acid present, a total amount of nitrogen in the nominal volume of fluid in container.

Nominal osmolality

Statement if the solution is nominally “hypotonic” or “hypertonic”

Nominal pH of sol’n

Words “SINGLE USE” or “SINGLE DOSE”

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Label shall include the name and proportion of any antimicrobial agent present in product.

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The statement “FOR EXTERNAL USE ONLY” printed in red color must appear on the PDP of the label.

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For products 10mL or less and enclosed in a primary pack.

Label must contain: Name of productCompany LogoStrengthMode of AdminBatch NumberExpiry Date

Must contain the informations required under general requirements and specific requirements (sections 2 - 5)(Name of Product – Injections)

When not practicable to set out particulars in full on a label on the container, particulars to in 9.1 (in red color) may be abbreviated, provided abbreviation is not ambiguous.

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Product consist of individual dosage unitsName of productCompany name or logoStrengthExpiry date

For products in strip or blister packsName of productStrengthExpiry date must appear every 2 unitsCompany name and Batch number

every strip of 10 units

Primary pack and other labelling materials must contain the requirements stated earlier.

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There a container or primary pack containing products is enclosed in a transparent covering and the particulars which are required to be set out on the label on the container or primary pack are clearly visible through the transparent covering.

Where products are made up or compounded by a pharmacist in a accordance with the individual prescription of a medicinal practitioner, dentist or veterinarian.

Products donated by foreign agencies/person, the requirements of generic labelling may be waived except that the expiry date must be indicated.

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The requirements do not apply for drugs used solely for investigational purpose and donated products by a foreign agency or person and in exceptional cases where the labelling provisions of this regulation are not appropriate.

These exemption must be applied for and approved by FDA in case to case basis.

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Manufacture, sale, offering for sale or transfer of any product that is misbranded.

Forging, counterfeiting, simulating or falsely representing or using any mark, stamp, label or other identification device required under the

regulation without proper authority.

The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labelling of the product, if such act is done while such product is held for sale and results in such article being misbranded.

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The use on the labelling of any product of any representation or suggestion that such product is approved by FDA or that complies with the provisions of this regulation, when in fact it does not.

The use, in labelling of product of any reference to any FDA report or document without clearance

from FDA

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For violation of AO55 s.1988, any or the following sanctions after due notice and summary hearing may be imposed by the Secretary of Health

- SUSPENSION or REVOCATION of the LTO of drug establishments and outlets and cancellation of Certificate of Product Registration.

- IMPOSITION of ADMINISTRATIVE FINES of NOT LESS THAN 1,000 Php NOR MORE THAN 5,000 Php

-Recall from the market of misbranded product(s)

-Confiscation of violative product(s)

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The imposition of sanctions stated earlier does not preclude the institution of appropriate criminal proceedings pursuant to Section 26 of RA3720, as amended and Section 12 of RA6675

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BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00


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BSP 3BWF 14:00 – 17:00

BSP 3CTTH 10:30 – 13:30

BSP 3FMS 13:00 – 16:00

BSP 3ITTH 07:00 – 10:00

BSP 3JMS 07:00 – 10:00

BSP 3LWF 10:00 – 13:00


Requirements




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AO 109 s.1969Prescription Drug

Label Symbol

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Prescription Drug Label Symbol

All drugs which requires the prescription of a physician, dentist, veterinarian or any person authorized and licensed by law to prescribe must bear the symbol: Rx R

x

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The symbol must be prominently placed on the PDP of the label and on any retail carton or wrapper for such container of each drug or pharmaceutical specialty. R

x

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Prescription Drug Label SymbolThe symbol must be of contrasting color to the background on which it appears, with no particular color required and SHALL NOT BE LESS THAN 50% of the shorter dimension of a rectangular label or shorter diameter of an elliptical or nearby elliptical label and NOT LESS THAN 50% of the area of the PDP for any other shape of label.

Rx

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Prescription Drug Label SymbolOverprinting and superimposition is allowed if the symbol meets the requirements indicated in these regulations and such overprinting or superimposition will not result in obliterating or rendering less legible the other required label statements. R

x

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Prescription Drug Label SymbolFor products packed in foil or similar wrapper, the symbol shall appear on the foil and outer container from which they are removed for dispensing.

Rx

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Prescription Drug Label SymbolFor products with an outer retail container, the placement of the symbol is waived on the immediate label of the inner container; provided, however the inner container is not intended to be sold separately. R

x

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In cases of ampules or other containers too small or otherwise unable to accommodate the label:

If sold w/o an individual outer container, the symbol shall appear on the outer container from which they are removed for dispensing or use

if with an outer retail container, the placement of the symbol is waived on the immediate label of the inner container, provided, however, the inner container is not intended to be sold separately.

Rx

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The symbol is not required on the retail carton or wrapper if it was easily visible through such carton or wrapper.

Any drug or pharmaceutical specialty not subject to the placement of the symbol but whose labelling bears the symbol shall be deemed to be misleading. R

x

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©to respective owner nciiracpenalozarph.weebly.com/uploads/1/0/1/4/10141231/pmc2...restore or...

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