MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....considerations, justification of acceptance criteria for the drug substance impurities.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....Justification should be provided for all proposed acceptance criteria included in the drug.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=77)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....Justification should be provided for all proposed acceptance criteria included in the drug.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=74)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material..
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Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=31)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...In this situation, the drug substance and/or drug product should meet the acceptance criteria.....It establishes the set of criteria to which a drug substance or drug product should conform to.....The following selection presents a representative sample of both the drug products and the types of tests and acceptance criteria..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=30)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...desired product, a product-related substance, microbial limits, volume in container.....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..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=25)

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