Chart 2.0: Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001) – Stability

Chart 2.0: Stability (Chart to be used as a guide only)
  Tablets Capsules Liquids & Gels Ointments & Creams Powders Injectables Suppositories Aerosols
Potency Assay all active ingredients as well as other "elements" outlined below
    Plus: preservatives, antioxidants, and bacteriostats if effectiveness not checked under Purity section Plus: preservatives, antioxidants, and bacteriostats if effectiveness not checked under Purity section Plus: complete testing data on reconstituted forms Plus: preservatives, antioxidants, and bacteriostats if effectiveness not checked under Purity section   Quantity delivered per spray for metered dose products
Physical Characteristics Containers: (1) Appearance of inner walls and cap interiors colour (2) Integrity of seals (3) Appearance and adhesion of label
  • dissolution
  • disintegration
  • odour
  • hardness
  • color
  • appearance
  • dissolution
  • disintegration
  • condition of shells
  • color
  • appearance
  • odour
  • viscosity
  • specific gravity
  • pH
  • clarity of solution
  • precipitation of ingredients
  • non-homogeneity of suspensions
  • homogeneity (gels)
  • odour
  • texture
  • pH
  • homogeneity
  • precipitation of ingredients
  • odour
  • texture
  • clarity of solution
  • homogeneity
  • pH (after reconstitution)
  • particle size
  • flow characteristics (inhalation powders)
  • clarity
  • particulate matter
  • pH
  • precipitation of ingredients
  • optical rotation
  • multiple dose vials: product integrity after initial use
  • melting point
  • homogeneity
  • net weight
  • delivery weight
  • delivery pressure
  • pH
  • delivery effectiveness (e.g. spray pattern and droplet size)
  • number of doses or sprays per package
Purity Containers: (1) Migration of drug into plastic (2) Migration of plasticisers into drug (3) Corrosion
  • moisture content
  • moisture content
  • sterility for ophthalmics
  • particulate matter for ophthalmics
  • sterility for ophthalmics
  • particulate matter for ophthalmics
  • moisture content
  • sterility
   
Microbial Test
Degradation products

Note: Chart 2.0 Stability is a guide for selecting parameters to be studied in the stability program. Each product must be examined separately.

  1. The inclusion of a sterility test in the stability study of a sterile drug may not be necessary if the container closure system has been proven to be hermetic.
  2. In addition to preservative content testing, a single regular production batch of the drug is to be tested for antimicrobial preservative effectiveness at the end of the proposed shelf life.
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