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Manufacturing > Labelling > Flashcards

Labelling Flashcards

1
Q

Requirements for Labelling Materials of Pharmaceutical Products

A

Administrative Order No. 55 s. 1988

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2
Q

Information included in the labeling materials

A
  1. Name of the product (Generic name alone or with Brand name, as the case may be)
  2. Dosage form and strength
  3. Pharmacologic category
  4. Rx symbol, in case of prescription drugs
  5. Name and complete address of manufacturer and trader, when applicable
  6. Net content
  7. Formulation
  8. Indication(s)
  9. Contraindication(s), precaution(s), warning(s)
  10. Mode of administration/directions for use
  11. Batch and lot number
  12. Expiry/ expiration date and date of manufacture
  13. Registration number
  14. Storage conditions
  15. For Rx products: Foods, drugs and devices and Cosmetic Act prohibits dispensing without prescription
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3
Q

All information required to appear on the label must be:

A

a. Written in English or Filipino
b. Clearly and prominently displayed
c. Readable with normal vision without straining. The color contrast, the position and spacing of the information must be taken into consideration in complying with labeling requirements.

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4
Q

Principal display panel

A

40% of the total surface of the container

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5
Q

Principal Display Panel Information

A

Formulation
Indication(s)
Mode of administration/directions (s) for use
Batch and lot number
Expiry/ expiration date and date of manufacture
Registration number
Storage conditions
For Rx: Foods, Drugs and devices and Cosmetic Act prohibits dispensing without prescription

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6
Q

Name of the Product

A
  • Generic Name shall be prominently printed element on the label
  • Enclosed exclusively by an oitline box
  • Background color inside the box, against with the generic name
  • Printed in Full
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7
Q

Generic Name with Brand Name

A

Same typeface, font, and size
Generic name appearing above the BN and a point size bigger than the BN

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8
Q

Two generic Name

A

Generic name of both API indicated within the box

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9
Q

3 or more generic Name

A

An official name for the combination, serve as the equivalent of the generic name designaed by BFAD

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10
Q

Dosage Form

A

Dosage form shall be specified including special delivery system

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11
Q

Pharmacologic Category

A

Shall conform to the category used in PNDF
N\If not classifief by BFAD, Approval of BFAD

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12
Q

Rx Symbol

A

Printed in a type size no less than one fifth (1/5) of the height of the principal displayed panel.
In contrasting color to the background

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13
Q

Overimprinting / Superimposition

A

Allowed as long it will not result in obliterating or rendering less legible the other required requirement

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14
Q

Formulation

A
  • Active ingredient(s) must be stated in their generic names (INN).
  • The amounts of the active ingredient(s) shall be expressed in the metric system or unit of potency, when applicable, as specified in the official compendia.
  • The salt or chemical form(s) of active ingredient(s) must be stated
  • Multiple components must be enumerated in the order of decreasing pharmacologic activity, when applicable.
  • The coloring agent and excipient causing hypersensitivity must be indicated
  • Alcohol content expressed in Percent %
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15
Q

Contraindications, Precautions, Warnings

A

Full information in contraindication the use of drugs
Warning statements as required by BFAD

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16
Q

Mode of Administration / Directions for Use

A

Full information for recommended dosage including the following:
* Initial Dose
* Optimal Use / Usual Dose
* Frequency Interval
* Duraction
* Dosage Adjustment

Dilution, Reconstitution, Preparation, and Administration Information
Separate directions for Adult & Children
“Adult Dose” - if not recommended for children

17
Q

Batch / Lot Number

A

Under once company: Only the batch no
Diff compoany: Lot No and Batch No
The batch and/or lot number must be printed on each strip of ten (10) blister units.

18
Q

Registration Number

A

Indicate the Drug registration Number and Code assigned by BFAD

18
Q

Registration Number

A

Indicate the Drug registration Number and Code assigned by BFAD

19
Q

Labeling of Biological Products

A

− The name and proportion of any antimicrobial agent in the product.
− The name of any adjuvant in the product or any substance which, when administered with an
antigen, modifies the immune response to that antigen.
− The name of the species of animal or organism from which the product has been prepared.
− For monoclonal antisera, the name of the species source
− For viral vaccines produced in animal cells or cell cultures, the name of the cell culture
substrate
− The potency of biological products shall be expressed as potency unit or weight of active substances per dose.
− The potency unit to be used shall be the International Unit has been established.
− Date of manufacture which pertains to the date (month and year)

20
Q

For monoclonal antisera

A

Name of the specie source or name of specie of orgin of the hybridoma cell used in the preparation of the product

21
Q

Viral Vaccines produced in Animals Cells or Cell Cultures

A

Name of the cell cultures substrate or name of animal and tissue
Name of residual antibiotic present in the producy

22
Q

Labeling of Injections

A

− The name and quantity of all excipients in the product except for large volume injections
− Recommended routes of administration such as “intravenous”, “intramuscular”, or
“subcutaneous”.
− Where an antimicrobial agent is not included in the product, the words “Use only once or discard
any remaining portion”
− Where the contents of the container are to be used on one occasion only, the words “single use”
or “single dose”.
− Where the products consist of a concentrated solution for injection, a direction not to
administer the solution undiluted and a direction to dilute the solution with the specified
diluents to the appropriate volume before use.

23
Q

Large Volume Injections

A

− The names and quantities of all excipients and active substances in the nominal volume of fluid
in the container, listed in descending order of magnitude within each group of chemically similar
substances.
− Where one or more substances are amino acids and/or protein, a statement of the total amount of
nitrogen in the nominal volume of fluid in the container.
− The nominal osmolality.
− A statement which specifies whether the solution is nominally “hypotonic” or
“hypertonic”.
− The nominal pH range of the solution.
− The words “single use” or “single dose”.

24
Q

Labeling of Topical Products

A

Name & Propotion of any antimicrobial agents present in product

25
Q

Labeling of Products for External Use

A

“FOR EXTERNAL USE ONLY” printed in red color must appear on the principal display panel of the label.

26
Q

Labeling Small Containers

A

Label of container
Company Logo
Strength
Mode of Administrayion
Batch Number
Expiration Date

27
Q

Labeling of Individually Wrapped Products, Strip, & Blister Packs

A
  • Where the product consist of individual dosage units, each individuals dosage unit is enclosed in primary pack
  • The primary Pack must contain general requirements
  • The individual wapper unit must contain: Company Name, Logo, Strength, Expiry Date
  • Strip or Blister Packs:
    For every two units: Strength, Expiration Date
    For every Strip of Ten: Company Name, Batch Number
28
Q

Exemptions in Complying w/ the labeling Requirement

A
  • If the products are enclosed in a transparent covering
  • If the products are compounded by the pharmacist
  • If the products are used solely for investigational use
  • If the products are donated by foreign agencies
29
Q

Amendments of A.O. 55 s. 1989

A

AO 64 s. 1989

30
Q

Caution for prescription Drugs

A

All Rx drugs shall carry the following caution:
For any Product belonging to List A or B
“Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription (List A/B)”

31
Q

Labels for Products containing >2 Active Ingr

A

Products containing two or more active ingredient shall have generic Name as determined by BFAD

32
Q

Lables for products in a strip or blister pack

A

Strength, expiry date, company name, and batch number must appear form every standard stip.

Manufacturing (13 decks)

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