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.....considerations, justification of acceptance criteria for the drug substance impurities..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of.....will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....appropriate FDA staff, call the appropriate number listed on the title page of this..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=95)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of.....will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....appropriate FDA staff, call the appropriate number listed on the title page of this..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=94)

...The proposed acceptance criteria for these parameters should ensure that the analytical procedure is.....We recommend that you review the tests, studies, analytical procedures, and acceptance criteria in.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on..
http://www.fda.gov/cder/guidance/protcmc.doc (score=80)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and tests should be instituted to control those drug substance parameters.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on.....Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation using a..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=78)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and tests should be instituted to control those drug substance parameters.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on.....Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation using a..
http://www.fda.gov/cder/guidance/2180dft.htm (score=78)

Draft Guidance for Industry: Comparability Protocols — Chemistry,...
...The proposed acceptance criteria for these parameters would ensure that the analytical procedure is.....We recommend you review the tests, studies, analytical procedures, and acceptance criteria in your.....Clearly explain each issue/concern and, when appropriate, include a proposed revision and..
http://www.fda.gov/cber/gdlns/cmprprot.htm (score=73)

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...including the analytical procedures that will be used, and acceptance criteria that will be achieved.....where appropriate, a reduced reporting category for future reporting of CMC changes.....procedures that will be used, and acceptance criteria that will be achieved to assess the effect of..
http://www.fda.gov/cber/gdlns/cmprprot.pdf (score=73)

Draft Guidance for Industry: Comparability Protocols -Protein Drug Products...
...The proposed acceptance criteria for these parameters should ensure that the analytical procedure is.....We recommend that you review the tests, studies, analytical procedures, and acceptance criteria in.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on..
http://www.fda.gov/cber/gdlns/protcmc.htm (score=73)

Container Closure Systems for Packaging Human Drugs and Biologics
...Appropriate tests and acceptance criteria for identification and for moisture content should be provided for both cotton.....Because these are considered primary packaging components, appropriate tests and acceptance criteria to establish.....The complete and assembled component and its parts should meet suitability criteria appropriate for..
http://www.fda.gov/cder/guidance/1714fnl.htm (score=71)

Guidance for Industry: Container Closure Systems for Packaging Human Drugs...
...Adequate information regarding the tests,methods, acceptance criteria, reference standards, and.....is encouraged to discuss significant variations in advance with the appropriate CDER.....2 In general, this guidance does not suggest specific test methods and acceptance criteria..
http://www.fda.gov/cber/gdlns/cntanr.pdf (score=71)

...The analytical procedure, validation of analytical procedures and justification of acceptance criteria, as.....When appropriate, specific tests and acceptance criteria to control microbial contamination should be included in the specification.....For example, proposing interim acceptance criteria would not be appropriate when the stability data package recommended in..
http://www.fda.gov/cder/guidance/3969DFT.doc (score=68)

Guidance for Industry - Container Closure Systems for Packaging Human Drugs...
...Appropriate tests and acceptance criteria for identification and for moisture content should be provided for both cotton.....Because these are considered primary packaging components, appropriate tests and acceptance criteria to establish.....The complete and assembled component and its parts should meet suitability criteria appropriate for..
http://www.fda.gov/cber/gdlns/cntanr.htm (score=68)

...The proposed acceptance criteria for these parameters would ensure that the analytical procedure is.....We recommend you review the tests, studies, analytical procedures, and acceptance criteria in your.....Clearly explain each issue/concern and, when appropriate, include a proposed revision and..
http://www.fda.gov/cder/guidance/5427dft.doc (score=68)

Guidance for Industry: Drug Substance Chemistry, Manufacturing, and...
...The tests and acceptance criteria appropriate for a particular naturally derived protein drug substance depend.....The analytical procedure, validation of analytical procedures and justification of acceptance criteria, as.....When appropriate, specific tests and acceptance criteria to control microbial contamination should be included in the specification..
http://www.fda.gov/cber/gdlns/drugsubcmc.htm (score=68)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....apply the content recommendations in this guidance, as scientifically appropriate, and/or.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=58)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....apply the content recommendations in this guidance, as scientifically appropriate, and/or.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=58)

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.....description include a complete discussion of the performance specifications and, when.....Protocol and acceptance criteria for value assignment and validation, including any specific..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=49)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...procedures and acceptance criteria which, stability of drug substance and drug product. A qualitative.....be minimized by the use of appropriate, well- characterization of the product as described.....A specification is defined as a list of tests, Acceptance Criteria for.. The text of the guidance..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=47)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical.....Shelf-Life Acceptance Criteria 2.3 In-Process Tests 2.4 Design and Development Considerations 2.5.....Where harmonization has been achieved, an appropriate reference to the harmonized..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=44)

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