MDI and DPI Drug Products
...For MDI and DPI drug products, certain studies should be performed to determine.....stability test storage conditions. Additional studies should be performed to characterize.....considerations, justification of acceptance criteria for the drug substance impurities..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...Appropriate acceptance specifications established by the botanical drug product manufacturer for the.....dissolution for solid oral dosage forms, sterility for parenterals, animal safety test for.....The use of appropriate starting materials and the drug substance manufacturer's ability to control the source depend on..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=28)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....of false-positive results arises in the sampling and transfer of the test aliquot from the.....errors and ensure that appropriate corrective action is taken to prevent their recurrence..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=9)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Equipment used in the production, processing, or packaging of a PET drug product should be appropriate for the.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....70, PET centers would have to ensure that each batch of PET drug product meets its established acceptance criteria, except..
http://www.fda.gov/cder/guidance/4259dft.htm (score=9)

Guidance for Industry
...product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of.....deviation is considered to have compromised the integrity of the sterility test, the test.....regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=9)

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