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
Potency			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
Physical Characteristics	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. 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. 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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2020-11-16