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)

57 FINAL SOFTWARE GUIDANCE COPY 2
...Software Requirements Specification, including predetermined criteria for acceptance of.....a software functional test plan with pass/fail criteria, data, and an analysis of the.....Unit, integration and system level test protocols including pass/fail criteria, test..
http://www.fda.gov/cdrh/ode/57.html (score=30)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A full description of the acceptance criteria and the test methods used to ensure the identity, assay, functionality.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on test.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results for submitted..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=20)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A full description of the acceptance criteria and the test methods used to ensure the identity, assay, functionality.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on test.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results for submitted..
http://www.fda.gov/cder/guidance/2180dft.htm (score=20)

Draft Guidance for FDA Review Staff and Sponsors - Content and Review of...
...We further recommend that you describe the specifications used for intermediate acceptance criteria.....Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, June.....Guideline on Validation of the Limulus Amebocyte Lysate test as an End-Product Endotoxin Test for Human and Animal..
http://www.fda.gov/cber/gdlns/gtindcmc.htm (score=18)

...During the clinical investigation process, the sponsor would establish tentative acceptance criteria.....The source, analytical procedures, and test results for the starting materials should be.....In setting subsequent acceptance criteria, relevant correlations should be established between data..
http://www.fda.gov/cder/guidance/3619fnl.doc (score=17)

Guidance for the Content of Premarket Submissions for Software Contained in...
...Unit, integration and system level test protocols, including pass/fail criteria, test report.....statement that testing will be conducted and meet specified acceptance criteria before the.....The documentation submitted should include system or device level test pass/fail criteria..
http://www.fda.gov/cdrh/ode/guidance/337.html (score=17)

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...provided on acceptance criteria, test procedures, and analytical sampling plans(i.e., number of samples tested.....The stability test parameters, with appropriate acceptance criteria, should..include those test parameters identified in the drug.....Appropriate, validated test procedures and corresponding acceptance criteria that..are reflective of the test results for submitted..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=17)

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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=17)

software guidance
...If specifications, design documentation, test plans and procedures are written for the.....concern determinations have already been made for specific devices and review criteria are.....acceptance criteria. Software safety requirements are derived from the preliminary hazard..
http://www.fda.gov/cdrh/ode/software.pdf (score=17)

software guidance
...If specifications, design documentation, test plans and procedures are written for the.....concern determinations have already been made for specific devices and review criteria are.....acceptance criteria. Software safety requirements are derived from the preliminary hazard..
http://www.fda.gov/cdrh/ode/dtswguid.html (score=17)

Guidance for Reviewers - Instructions and Template for Chemistry,...
...indicating assays, which may be different from final product release criteria test methods, for.....Acceptance criteria are the numerical limits, ranges, or other criteria for the tests.....You should assess the sponsor's proposed release acceptance criteria for the final product..
http://www.fda.gov/cber/gdlns/cmcsomcell.pdf (score=17)

Microsoft Word - 3619fnl.doc
...procedures, acceptance criteria, test time points for each of the tests, storage conditions,and the duration of.....Any change in the tentative specification, including the tentative acceptance criteria,should be.....The analytical results for each test should be reported.Representative chromatograms..
http://www.fda.gov/cder/guidance/3619fnl.pdf (score=17)

Guidance for Industry - Container Closure Systems for Packaging Human Drugs...
...Standards or acceptance criteria, test methods, and, where indicated, methods of cleaning, sterilizing, and.....An adequately detailed description of the tests, methods, acceptance criteria, reference standards.....c Note that an applicant's acceptance tests may include, among others, test parameters indicated under the description, suitability..
http://www.fda.gov/cber/gdlns/cntanr.htm (score=17)

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -...
...The stability test parameters, with appropriate acceptance criteria, should include those test parameters identified in the drug.....Appropriate, validated test procedures and corresponding acceptance criteria that are reflective of the test results for submitted.....Information should also be provided on acceptance criteria, test procedures, and analytical sampling..
http://www.fda.gov/cder/guidance/4234fnl.htm (score=17)

Guidance for FDA Review Staff and Sponsors: Content and Review of...
...describe the specifications used for intermediate acceptance criteria and final product.....sensitivity and specificity of test methods when appropriate, release criteria, and test.....FDA recommends that proposed release acceptance criteria for the final product be based on..
http://www.fda.gov/cber/gdlns/gtindcmc.pdf (score=17)

Draft Guidance for Reviewers: Instructions and Template for Chemistry,...
...You should assess the appropriateness of acceptance criteria based on any results previously obtained.....The results of this test should meet acceptance criteria as part of required final product.....Guideline on Validation of the Limulus Amebocyte Lysate test as an End-Product Endotoxin Test for Human and Animal..
http://www.fda.gov/cber/gdlns/cmcsomcell.htm (score=17)

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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=14)

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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=14)

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=12)

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