MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Guidance- Content & Format CMC for Vaccine & Related Product
...new lots of reference standards and acceptance criteria for a new reference standard.....This guidance document represents FDA's current thinking on the content and format of the.....significant phases of production, the criteria for accepting or rejecting an in-process..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=34)

...We recommend you use the following steps to identify sampling locations and acceptance criteria prior.....The subsections below describe how to assess the adequacy of powder mix, uniformity of.....If test results fail stage 1 criteria, you should conduct extended testing to stage 2 acceptance..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0493-gdl0001.doc (score=23)

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...Format and Content of the Human Pharmacokinetics and Bioavailability Section of an.....Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug.....Content and Format of INDs for Phase 1 Studies of Drugs Including Well-Characterized, 10/4..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=23)

Guidance for the Content of Premarket Submissions for Software Contained in...
...statement that testing will be conducted and meet specified acceptance criteria before the product is.....Guidance for the Content of Premarket Submissions for Software Contained in Medical.....Guidance for the Content of Premarket Submissions for Software Contained in Medical..
http://www.fda.gov/cdrh/ode/guidance/337.html (score=21)

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