MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....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)

FOOD AND DRUG ADMINISTRATION
...A cartoon was drawn with PAT acceptance criteria range on the Y-axis correlated to the..approved.....Replacement test correlated with something else. - Correlate process end point/signal to.....Different/related acceptance criteria with PAT testing.- Re-evaluated/renegotiated acceptance..
http://www.fda.gov/ohrms/dockets/ac/02/minutes/3869M1_01_PATSubcommittee-Product-ProcessWG.pdf (score=86)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....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..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=53)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....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..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=53)

Chem Revs. of DMFs for DSIs
...Test Procedures..and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances International.....If a stability-indicating test is used which is different from the release test, this.....appropriate acceptance criteria that are numerical limits, ranges, or other..criteria for the tests..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=47)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...When describing your acceptance criteria or summary data, we recommend that you include the slope.....and testing and should briefly describe the methods or tests used and a summary of the.....Protocol and acceptance criteria for value assignment and validation, including any specific..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=44)

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...production or produces additional impurities, appropriate tests, acceptance criteria, procedures, and.....assure that the test sample is representative of the entire batch is provided in.....meet the acceptance criteria will not be released or, if already distributed, will be withdrawn from..
http://www.fda.gov/cder/guidance/cmcsample.pdf (score=41)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...When antimicrobial preservative content testing is performed as an in-process test, the acceptance criteria.....When antioxidant content testing is performed as an in-process test, the acceptance criteria should remain part.....When antioxidant content testing is performed as an in-process test, the acceptance criteria should remain part..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=39)

Class II Special Controls Guidance Document: Serological Reagents for the...
...We may also request additional information if we need it to assess the adequacy of your acceptance.....If you modify a suggested test method, you may cite the method but should provide.....So that acceptance criteria or data summaries can be best interpreted during the review, we recommend..
http://www.fda.gov/cdrh/oivd/guidance/1206.html (score=36)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...When the quality control unit has determined that a lot of material has met all acceptance criteria.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....When it is determined that all acceptance criteria have been met, the PET center should then provide..
http://www.fda.gov/cder/guidance/4259dft.htm (score=34)

Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation...
...We may also request additional information if we need it to assess the adequacy of your acceptance.....If you modify a suggested test method, you may cite the method but should provide.....3If FDA makes a substantial equivalence determination based on acceptance criteria, the subject..
http://www.fda.gov/cdrh/oivd/guidance/1236.html (score=33)

The scope of the safe harbor concept when applied to new/rapid...
...Parallel testing and retesting might be considered since the counts and acceptance criteria may be.....The safe harbor concept for sterility testing using new/rapid microbiological test methods.....How can new acceptance criteria be established using different measures? Should there be application..
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3901B1_02_Rapid%20Microbiology.htm (score=31)

Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA)...
...We may also request additional information if we need it to assess the adequacy of your acceptance.....If you modify a suggested test method, you may cite the method but should provide.....3 If FDA makes a substantial equivalence determination based on acceptance criteria, the subject..
http://www.fda.gov/cdrh/ode/guidance/668.html (score=31)

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=30)

Class II Special Controls Guidance Document: AFP-L3% Immunological Test...
...The report should also include a summary of the test data or description of the acceptance criteria applied to address the risks.....We may also request additional information if we need it to assess the adequacy of your acceptance.....If you modify a suggested test method, you may cite the method, but should provide..
http://www.fda.gov/cdrh/oivd/guidance/1570.html (score=23)

...This can be accomplished by examining and/or testing to ensure that the acceptance criteria are met.....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..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=23)

Class II Special Controls Guidance Document: Breath Nitric Oxide Test System
...For your data summary or acceptance criteria to be properly interpreted during the review process, we.....methods or tests used and a summary of the test data or description of the recognized.....breath nitric oxide test system combines chemiluminescence detection of nitric oxide with..
http://www.fda.gov/cdrh/oivd/guidance/1211.pdf (score=21)

Guidance In the Manufacture and Clinical Evaluation of In Vitro Tests to...
...validation of coating methods including ratios used and acceptance criteria for the.....licensed HIV-1 antibody test kit and in June 1996, a supplemental Western Blot test to.....Specificity and Sensitivity Studies for Test Kits with a Proposed Labeling for Screening..
http://www.fda.gov/cber/gdlns/hivnas.pdf (score=20)

Class II Special Controls Guidance Document: Instrumentation for Clinical...
...If the finished device does not meet the acceptance criteria and, thus, differs from the device.....A specific multiplex assay or test that is intended to be run on instrumentation for.....3 If FDA makes a substantial equivalence determination based on acceptance criteria, the..
http://www.fda.gov/cdrh/oivd/guidance/1546.pdf (score=19)

Class II Special Controls Guidance Document: Instrumentation for Clinical...
...The report should also include a summary of the test data or description of the acceptance criteria applied to address the risks.....We may also request additional information if we need it to assess the adequacy of your acceptance.....Depending on the nature of the multiplex test for use with the instrumentation, the..
http://www.fda.gov/cdrh/oivd/guidance/1546.html (score=19)

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