MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....discuss significant departures from the approaches outlined in this guidance with the.....quantitative test with appropriate acceptance criteria should be established for the.. 474..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...Appropriate acceptance specifications established by the botanical drug product manufacturer for the.....dissolution for solid oral dosage forms, sterility for parenterals, animal safety test for.....These regulations require documentation of the drug substance, drug product, placebo, labeling, and an..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=29)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Equipment used in the production, processing, or packaging of a PET drug product should be appropriate for the.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....70, PET centers would have to ensure that each batch of PET drug product meets its established..
http://www.fda.gov/cder/guidance/4259dft.htm (score=18)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....appropriate specifications for acceptance or rejection of each lot of components that.....deviation is considered to have compromised the integrity of the sterility test, the test..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=13)

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.....errors and ensure that appropriate corrective action is taken to prevent their recurrence..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=13)

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.....A list of tests, references to analytical procedures, and appropriate acceptance criteria that are.....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=9)

OOS draft guidance
...appropriate specifications, standards, and test procedures that are designed to ensure.....Outlier tests have no applicability in cases where the variability in the product is what.....includes all suspect results that fall outside the specifications or acceptance criteria..
http://www.fda.gov/cder/guidance/1212dft.pdf (score=8)

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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.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=8)

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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.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=8)

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