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

...This can be accomplished by examining and/or testing to ensure that the acceptance criteria are met.....dissolution for solid oral dosage forms, sterility for parenterals, animal safety test for parenterals, when.....Appropriate acceptance specifications established by the botanical drug product manufacturer for the..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=27)

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.....A list of tests, references to analytical procedures, and appropriate acceptance criteria.....For modified-release dosage forms, appropriate test conditions and sampling procedures should be..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=11)

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the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....If appropriate, this draft guidance will be revised and republished for comment in..
http://www.fda.gov/cder/guidance/4259dft.htm (score=11)

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=10)

Guidance for Industry
...regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic.....appropriate specifications, standards, sampling plans, and test procedures designed to.....A firm's use of media fill acceptance criteria allowing infrequent contamination does not..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=9)

Class II Special Controls Guidance Document: Drug Metabolizing Enzyme...
...The report should also include a summary of the test data or description of the acceptance criteria applied to address the risks.....Use appropriate test samples at multiple DNA concentrations, similar to the concentrations.....We may also request additional information if we need it to assess the adequacy of your acceptance..
http://www.fda.gov/cdrh/oivd/guidance/1551.html (score=8)

Guidance for Industry and FDA Staff: Class II Special Controls Gudiance...
...If the finished device does not meet the acceptance criteria and, thus, differs from the device.....We recommend that you evaluate test samples that encompass all genotypes in the test.....identify the appropriate FDA staff, call the number listed on the title page of this..
http://www.fda.gov/cdrh/oivd/guidance/1551.pdf (score=8)

OOS draft guidance
...includes all suspect results that fall outside the specifications or acceptance criteria established.....appropriate specifications, standards, and test procedures that are designed to ensure.....The CGMP regulations require that statistically valid quality control criteria include..appropriate acceptance and/or..
http://www.fda.gov/cder/guidance/1212dft.pdf (score=8)

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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.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=7)

þÿ
...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.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=7)

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.....description include a complete discussion of the performance specifications and, when..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=6)

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 cannot identify the appropriate FDA staff, call the appropriate number listed on.....If you modify a suggested test method, you may cite the method but should provide..
http://www.fda.gov/cdrh/oivd/guidance/1206.html (score=5)

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 cannot identify the appropriate FDA staff, call the appropriate number listed on.....If you modify a suggested test method, you may cite the method but should provide..
http://www.fda.gov/cdrh/oivd/guidance/1236.html (score=4)

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.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....We may also request additional information if we need it to assess the adequacy of your acceptance..
http://www.fda.gov/cdrh/oivd/guidance/1570.html (score=3)

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.....identify the appropriate FDA staff, call the appropriate number listed on the title page..
http://www.fda.gov/cdrh/oivd/guidance/1211.pdf (score=3)

stability guidance -draft
...acceptance criteria of such parameters, and the test methodology used to assess such.....should be assayed for the chemical content of the preservatives at all appropriate test.....such cases, alternate approaches, such as qualifying higher acceptance criteria for a..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=3)

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.....appropriate test samples are obtained for all donations included in a pool and..that all..
http://www.fda.gov/cber/gdlns/hivnas.pdf (score=3)

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
...criteria that are numerical limits, ranges, or other criteria for the test described. 1842.....appropriate ICH Expert Working Group, is transmitted by the ICH Steering.. Committee to.....25 Acceptance criteria for residues and the choice of cleaning procedures and.. 397..
http://www.fda.gov/cder/guidance/4011dft.pdf (score=3)

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.....identify the appropriate FDA staff, call the appropriate number listed on the title page.....A specific multiplex assay or test that is intended to be run on instrumentation for..
http://www.fda.gov/cdrh/oivd/guidance/1546.pdf (score=3)

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