MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....considerations, justification of acceptance criteria for the drug substance impurities.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....Justification should be provided for all proposed acceptance criteria included in the drug.....associated acceptance criteria depend on the route of administration of the drug product..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=81)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....Justification should be provided for all proposed acceptance criteria included in the drug.....associated acceptance criteria depend on the route of administration of the drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=79)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=70)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...70, PET centers would have to ensure that each batch of PET drug product meets its established.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface.....When the quality control unit has determined that a lot of material has met all acceptance..
http://www.fda.gov/cder/guidance/4259dft.htm (score=68)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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=40)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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=38)

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 data from a single representative manufacturing site are used in setting tests and acceptance criteria..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=34)

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=28)

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