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)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...To maintain optimal performance characteristics for the drug product, acceptance criteria for the leak rate should.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results.....Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation using a microscopic test..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=20)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...To maintain optimal performance characteristics for the drug product, acceptance criteria for the leak rate should.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results.....Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation using a microscopic test..
http://www.fda.gov/cder/guidance/2180dft.htm (score=20)

Draft Guidance for FDA Review Staff and Sponsors - Content and Review of...
...Specifications should be appropriate to the stage of product development, because release criteria are generally.....An appropriate test of vector supernatant lots would be by amplification on a permissive cell line.....Document in your review basic information concerning the drug component, such as the drug name, vendor or source..
http://www.fda.gov/cber/gdlns/gtindcmc.htm (score=18)

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=18)

þÿ
...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=17)

þÿ
...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=17)

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=10)

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=10)

Las Vegas Injury Lawyer