MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....stability test storage conditions. Additional studies should be performed to characterize.....drug products should be controlled with appropriate acceptance criteria and test methods..
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.....process test and the drug substance test, the acceptance criterion for the in-process test.....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.....process test and the drug substance test, the acceptance criterion for the in-process test.....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.....of false-positive results arises in the sampling and transfer of the test aliquot from the.....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.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface..
http://www.fda.gov/cder/guidance/4259dft.htm (score=67)

Chem Revs. of DMFs for DSIs
...and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances International Conference on.....If a stability-indicating test is used which is different from the release test, this.....If a drug product available for oral use is then submitted as an..ophthalmic product..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=54)

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...substance obtained from the synthesis and purification procedure is collected in the drug.....assure that the test sample is representative of the entire batch is provided in.....production or produces additional impurities, appropriate tests, acceptance criteria..
http://www.fda.gov/cder/guidance/cmcsample.pdf (score=42)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...It is normally not considered necessary to test the drug product for synthesis impurities that are.....For oral products requiring reconstitution, a test and acceptance criterion for water content.....In general, it is advisable to test the drug product unless its components are tested before manufacture..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=34)

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