L2: Standards and Specifications

• Areas of Consideration

  • Formula
  • Raw Material Specification
  • Standard Operating Procedure (SOP)
  • Finished Product Specification
  • Packaging Material Standard
  • Testing Methods
• Concise and precise statement of the ingredients with percentages and accurate weights

  Formula
• Enumerate the characteristics of all materials that go into a product and the permissible range of purity of each ingredient

  Raw Material Specification
• NF


  National Formulary
• USP

  United States Pharmacopeia
• BP


  British Pharmacopoeia
• BPC


  Bulk Pharmaceutical Chemical
• Examples of Raw Material Specification

  NF, USP, BP, BPC
• A step-by-step method on how to go about a job: must contain precise instructions and information that assure variations in production within an acceptable established range.

  Standard Operating Procedure
• Covers characteristics that affect the proper performance, purity, safety and stability of the product

  Finished Product Specification
• Tolerances may be minimum, maximum or both


  Finished Product Specification
• Information shall be provided on the construction of the container, with a list of the different components, the type of materials used in the different parts, and the nature of the polymers.


  Packaging Material Standard
• In the Packaging Material Standard, specifications must be set for:

  • Bottles, jars, cans
  • Aluminum foil
  • Cellophane
  • Caps, cap liners
  • Printed inserts
  • Cartons, shipping case
  • Wrapping paper
• Test procedures must be standardized, results must be precise and accurate even when handled by different operators


  Testing Methods
• Results of test must be validated


  Testing Methods