MDI and DPI Drug Products
...discuss significant departures from the approaches outlined in this guidance with the.....quantitative test with appropriate acceptance criteria should be established for the.. 474.....The stability test parameters, with appropriate acceptance criteria, should include.. 1240..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...Appropriate acceptance specifications established by the botanical drug product manufacturer for the.....We recommend that this test be performed for crude extracts from natural sources.....dissolution for solid oral dosage forms, sterility for parenterals, animal safety test for parenterals, when..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=28)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...If the result of any BET exceeds the acceptance limit, or if a sterility test is positive.....errors and ensure that appropriate corrective action is taken to prevent their recurrence.....of false-positive results arises in the sampling and transfer of the test aliquot from the..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=9)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...If the result of any BET exceeds the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....If appropriate, this draft guidance will be revised and republished for comment in.....The reliability of the supplier's test results can be established by conducting..
http://www.fda.gov/cder/guidance/4259dft.htm (score=9)

Guidance for Industry
...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.....appropriate written specifications for the acceptance of each lot within each shipment of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=9)

OOS draft guidance
...appropriate specifications, standards, and test procedures that are designed to ensure.....includes all suspect results that fall outside the specifications or acceptance criteria.....Specifically, the guidance discusses how to investigate suspect, or OOS test results..
http://www.fda.gov/cder/guidance/1212dft.pdf (score=9)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...For oral products requiring reconstitution, a test and acceptance criterion for water content.....For modified-release dosage forms, appropriate test conditions and sampling procedures.....A list of tests, references to analytical procedures, and appropriate acceptance criteria that are..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=9)

þÿ
...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.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=3)

þÿ
...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.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=3)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...and testing and should briefly describe the methods or tests used and a summary of the.....data or description of the acceptance criteria applied to address the risks identified in.....description include a complete discussion of the performance specifications and, when..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=2)

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