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)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....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..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=83)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....process test and the drug substance test, the acceptance criterion for the in-process test.....associated acceptance criteria depend on the route of administration of the drug product..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=82)

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...18 The applicant and/or drug product manufacturer must establish the reliability of the.....process test and the drug substance test, the acceptance criterion for the in-process test.....associated acceptance criteria depend on the route of administration of the drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=80)

Document
...as safe and effective and not misbranded active ingredients in OTC drug products document.....definition test, there was at least a 20- the last antiperspirant application. controlled.....product effectiveness. revising the guidelines to state: revising the relative humidity..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=47)

FR Doc 03-14140
...Any drug product labeled, represented, or promoted for use as an OTC antiperspirant drug that.....The comments contended that the user perception test is not reliably indicative of product.....The agency needs appropriate effectiveness data and an appropriate USP-NF monograph..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=47)

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