FOOD AND DRUG ADMINISTRATION
...A cartoon was drawn with PAT acceptance criteria range on the Y-axis correlated to the.....Replacement test correlated with something else. - Correlate process end point/signal to.....Different/related acceptance criteria with PAT testing.- Re-evaluated/renegotiated..
http://www.fda.gov/ohrms/dockets/ac/02/minutes/3869M1_01_PATSubcommittee-Product-ProcessWG.pdf (score=100)

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...assure that the test sample is representative of the entire batch is provided in.....production or produces additional impurities, appropriate tests, acceptance criteria.....If a stabilizer is added, test for the assay of stabilizer should be included in the..
http://www.fda.gov/cder/guidance/cmcsample.pdf (score=58)

Guidacne for Industry: Testing Limits in Stability Protocols for...
...Both the 10 and 15-test studies have been approved as stability protocols for standardized.....From this Table,the probability of acceptance for a lot of rp=1 is 0.980, indicating that.....Consider now a 10 test study, where failure is designated as the first instance in which a..
http://www.fda.gov/cber/gdlns/grasstab.pdf (score=58)

Guidance for Industry - Testing Limits in Stability Protocols for...
...Section 6 presents options for the manufacturer when a test fails at a time point, and.....From this Table, the probability of acceptance for a lot of rp=1 is 0.980, indicating that.....Consider now a 10 test study, where failure is designated as the first instance in which a..
http://www.fda.gov/cber/gdlns/grasstab.htm (score=58)

Chem Revs. of DMFs for DSIs
...If a stability-indicating test is used which is different from the release test, this.....Test Procedures..and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances.....appropriate acceptance criteria that are numerical limits, ranges, or other..criteria for..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=58)

MDI and DPI Drug Products
...stability test storage conditions. Additional studies should be performed to characterize.....drug products should be controlled with appropriate acceptance criteria and test methods.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=21)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....Justification for an in-process test that is used in lieu of a drug substance test should.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=19)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....Justification for an in-process test that is used in lieu of a drug substance test should.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=19)

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.....of false-positive results arises in the sampling and transfer of the test aliquot from the.....ensure that each batch of PET drug product meets its established acceptance criteria, 1201..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=18)

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.....The reliability of the supplier's test results can be established by conducting.....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=18)

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.....When describing your acceptance criteria or summary data, we recommend that you include..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=18)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...For oral products requiring reconstitution, a test and acceptance criterion for water content.....When antimicrobial preservative content testing is performed as an in-process test, the acceptance.....When antioxidant content testing is performed as an in-process test, the acceptance criteria should..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=18)

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