Las 2-5

• Label


  Display of written, printed or graphic matter upon the immediate container
• Labelling

  All labels and other written, printed, or graphic matter upon any article or any of its container or wrapper or accompanying of such articles
• Inner label

  The label on or affixed to an immediate container
• Outer label


  The label on or affixed to the outside package of a drug such as carton label, or on a box containing a bottle of a drug
• Packaging material


  All items used or attached to bind, enclose or contain the drug or preparation in the final form for market presentation of the product
• Principal display panel


  Part of a label that is most likely to be displayed, presented or shown
• Batch


  A specific homogeneous quantity of a drug produced according to a single manufacturing order during the same cycle of manufacture
• Lot


  A batch or any portion of a batch of a drug or, in the case of a drug produced in a unit of time or quantity in a manner that assures its uniformity and quality within specified limits
• Labelling requirements

  • Name of Product
  • Pharmacologic Category
  • Formulation
  • Indication
  • Dosage and Mode of Administration
  • Warnings, Contraindications, and Precautions
  • Package inserts
  • Statement of reference for detailed information contained in the package inserts
  • Names and addresses of the manufacturer/importer/distributor/licensee/repacker
  • Lot number/Batch number
  • Expiration Date
  • Registration number
  • Net content
  • Storage conditions
  • Container
• Rx symbol and prescription requirement for caution must be prominently placed on the principal display panel of the label and/or on the panel normally displayed on the shelf
• Rx symbol must have a contrasting color to the background on which it appears
• Rx symbol must not be less than 50% of the area of the principal display panel for any other shape of label
• For products individually packed in foil or similar wrapper, the symbol shall appear on the foil and outer container from which they are removed for dispensing for use
• In cases of ampoules or other container, if too small or otherwise unable to accommodate a label, if sold without an individual outer container, the symbol shall appear on the outer container from which they are removed for dispensing for use
• Prescription requirement for caution must appear on the inner and outer retail container as follows; Caution: Food, Drug and cosmetic law prohibits dispensing without precaution
• The word “POISON” and Vignette representing a skull and cross in prominent big letters should be printed on red labels
• The product intended for external use, the statement “For External Use Only” printed in red color shall appear on the inner and outer label of the container
• The warning statement should appear on the inner and outer label of the product: Warning: “Keep Out of Reach of Children”
• Requirements for information on the label

  • Clearly and prominently displayed
  • Readable with normal vision without staining
  • Color contrast
  • Position and spacing of the information
• Labelling of drugs in small containers

  • The proper name of the drug
  • The category of the drug
  • The potency of the drug
  • Net content
  • The route of administration
  • The name and address of manufacturer/distributor
  • The lot number of the drug
  • The expiration date of the drug
  • The registration number of the drug
• FDA guidelines on package inserts

  • Name of the Product
  • Formulation
  • Description of the Product
  • Pharmacology
  • Indications
• Name of the Product

  Must be printed most prominently as the title
• Formulation


  Consists of generic name and other scientifically recognized terms in English referring to the active ingredient and the amount expressed per dosage unit
• Description of the Product


  Description of the physical and chemical properties of the active substances relevant to the formulation of the product and its pharmacologic actions
• Pharmacology


  Brief pharmacologic profile of the drug based on the animal and human studies
• Indications


  Refers only to the Bureau of Food and Drugs approved clinical use of the product based on substantial evidence of the efficacy and safety of the drug in the given dosage form
• Tablet


  Solid dosage forms containing drug substances with or without suitable excipients and prepared either by compression or molding methods intended for oral administration for local and systemic effects
• Tablet components

  • Diluents or fillers
  • Binders or adhesives
  • Disintegrants or disintegrating agents
  • Anti-adherents, glidants, lubricants
• Quality control tests for tablets ensure safety, potency, efficacy, stability, patient acceptability and patient compliance of the tablet
• Quality control tests check if the tablet satisfies certain standards to claim it to be a quality drug or not
• Quality control tests check that the quality parameters are within acceptance limits or not
• Tablet machine parts

  • Hopper for storing the material for compression
  • Feed frame for distributing material into the dies
  • Dies for controlling size and shape of tablets
  • Punches for compacting the material within the dies
  • Cams for guiding and punches
• Quality standards & compendial requirements


  • Tablet weight and tablet variation
  • Content uniformity test
  • Tablet thickness
  • Tablet friability
  • Tablet hardness
  • Tablet disintegration
  • Tablet dissolution
• According to USP, weight variation test is run by weighing 20 tablets individually calculating the average weights and comparing the individual tablet weights to the average
• The value of weight variation test is expressed in percentage
• Tablet weight variation limits according to USP

  • Average weight of tablet < 130 mg: 10%
  • Average weight of tablet 130-324 mg: 7.5%
  • Average weight of tablet > 324 mg: 5%
• Content uniformity test is a crucial quality control process in the pharmaceutical industry to ensure that each dosage unit of a batch contains the active pharmaceutical ingredient (API) within the specified limits
• Content uniformity test steps

  1. Select dosage units

  2. Dissolve/extract API

  3. Analyze solution

  4. Calculate mean and standard deviation

  5. Additional testing if needed
• For the initial 10 units, the relative standard deviation should be within acceptable limits (e.g., not more than 6.0%), and the mean content should be within 85-115% of the labeled claim
• If the initial test fails, test an additional 20 units