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)

57 FINAL SOFTWARE GUIDANCE COPY 2
...a software functional test plan with pass/fail criteria, data, and an analysis of the.....This is helpful for determining the appropriate degree of rigor and the kinds of risk.....Unit, integration and system level test protocols including pass/fail criteria, test..
http://www.fda.gov/cdrh/ode/57.html (score=37)

Microsoft Word - 355-CE~1.DOC
...suggests some important evaluation criteria, test procedures, and end points that FDA feels are.....It would also be appropriate to include the following in the ball labeling: 1 The ball.....these bounds to be determined substantially equivalent if the mechanical test results are..
http://www.fda.gov/cdrh/ode/355.pdf (score=36)

Microsoft Word - 916-MO~1.DOC
...Therefore, it suggests some important evaluation criteria, test procedures, and end points that FDA.....Roughness and appropriate dimensions of each test specimen must be measured before and.....possible test methods, rationale/purpose of each test, pass/fail criteria or typical results for each test..
http://www.fda.gov/cdrh/ode/916.pdf (score=22)

Microsoft Word - 827--P~1.DOC
...Numerous test reports describing the physical characteristics and mechanical performance.....microphotographs at appropriate magnifications and locations within the modified surface.....evaluation criteria, test procedures and end points. There may be circumstances where an..
http://www.fda.gov/cdrh/ode/827.pdf (score=22)

CBER - Blood Action Plan
...The Deputy Director, CBER and the ACRA will meet with appropriate staff until all blood.....criteria, test requirements and reentry. Where feasible, FDA will issue guidance to eliminate.....appropriate studies, risk assessment, communication, and any needed prevention strategies..
http://www.fda.gov/cber/blood/bap.htm (score=21)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on test results for.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results.....A full description of the acceptance criteria and the test methods used to ensure the identity, assay..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=21)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on test results for.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results.....A full description of the acceptance criteria and the test methods used to ensure the identity, assay..
http://www.fda.gov/cder/guidance/2180dft.htm (score=21)

Draft Guidance for FDA Review Staff and Sponsors - Content and Review of...
...An appropriate test would include monolayer cultures of the same species and tissue as that used for.....Tabulation of Final Product Release Criteria Tests, Test Methods, Specification, Test.....Specifications should be appropriate to the stage of product development, because release..
http://www.fda.gov/cber/gdlns/gtindcmc.htm (score=21)

Guidance for the Content of Premarket Submissions for Software Contained in...
...Unit, integration and system level test protocols, including pass/fail criteria, test report.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....The documentation submitted should include system or device level test pass/fail criteria and a summary..
http://www.fda.gov/cdrh/ode/guidance/337.html (score=21)

Guidance for Industry
...preparation of rubber stoppers should meet appropriate quality control criteria and not.....deviation is considered to have compromised the integrity of the sterility test, the test.....appropriate specifications, standards, sampling plans, and test procedures designed to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=8)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...Deviations from written specifications, standards,sampling plans, test procedures, or.....the batch selection criteria and analytical data that will be evaluated to determine.....FDA expects appropriate CGMPs to be applied to all steps of an API manufacturing process..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=8)

FR Doc 03-5401
...These requirements, if finalized, would ensure that manufacturers establish and use appropriate.....The working group issued a report that discussed the selection of the most appropriate and reliable identity test and the.....For example, it may be appropriate to require one type of test for confirming the identity of amino acids and another type of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.html (score=8)

Document
...definition test, there was at least a 20- the last antiperspirant application. controlled.....at 20 percent sweat reduction, met one of the extra effective criteria. active ingredient.....appropriate effectiveness data and an .. aluminum in the blood enters the brain, VerDate..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=8)

FR Doc 03-14140
...Evaluation of the Z values for the two 1-hour test days and the 24-hour test day showed that both products were.....The agency needs appropriate effectiveness data and an appropriate USP-NF monograph.....Thus, these studies showed that the 25-percent aluminum chlorohydrate met the Panel's..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=8)

March/April 1999 FDA Veterinarian Newsletter
...The test methods to determine the concentration of the active ingredient in Type A.....The evaluation criteria for Type C Medicated feed methods are the same whether the methods.....The test method must be in an SOP format supported by appropriate validation data, and..
http://www.fda.gov/cvm/index/fdavet/1999/march.html (score=7)

þÿ
...process test and the drug substance test, the acceptance criterion for the in-process test.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=7)

þÿ
...process test and the drug substance test, the acceptance criterion for the in-process test.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials.....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)

Class II Special Controls Guidance Document: Serological Reagents for the...
...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.....In developing the guidance, we carefully considered the relevant statutory criteria for..
http://www.fda.gov/cdrh/oivd/guidance/1206.html (score=7)

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.....description include a complete discussion of the performance specifications and, when..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=7)

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