MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....recommended for inclusion in the application regarding the components, manufacturing.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....evaluation can include testing of the material (see Section VI, Control of Components, 276.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=37)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The acceptance criteria should at a minimum meet the criteria proposed in The Pharmacopeial Forum.63.....Compounding sterile products from sterile components using proper techniques and equipment.....At a minimum, the acceptance criteria should meet the criteriaproposed in the Pharmacopeial Forum.58..
http://www.fda.gov/cder/fdama/difconc.htm (score=27)

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