MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....an internal reservoir containing sufficient formulation for multiple doses that are.....considerations, justification of acceptance criteria for the drug substance impurities..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....accelerator operation, radiochemical synthesis, purification steps, and formulation of the.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=59)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....including the analytical procedures that will be used, and acceptance criteria that will.....CMC changes on the identity, strength, quality, purity, and potency of a specific drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=34)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....including the analytical procedures that will be used, and acceptance criteria that will.....CMC changes on the identity, strength, quality, purity, and potency of a specific drug product..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=32)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...10 Impact of Drug Substance on Drug Product Specifications In general, it should not be necessary to test the.....The following selection presents a representative sample of both the drug products and the types of tests and acceptance criteria.....If changes in formulation or process variables significantly affect dissolution, and such..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=28)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...Cell substrate-derived, employed will vary from product to product, structure of the carbohydrate.....procedures and acceptance criteria which, stability of drug substance and drug product. A.....either the drug substance or drug product. product, which may occur during storage, a drug substance should be..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=25)

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