MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....considerations, justification of acceptance criteria for the drug substance impurities.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

þÿ
...associated acceptance criteria depend on the route of administration of the drug product and the.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....Justification should be provided for all proposed acceptance criteria included in the drug..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=51)

þÿ
...associated acceptance criteria depend on the route of administration of the drug product and the.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....Justification should be provided for all proposed acceptance criteria included in the drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=50)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...If data from a single representative manufacturing site are used in setting tests and acceptance criteria.....It establishes the set of criteria to which a drug substance or drug product should conform to be considered.....The following selection presents a representative sample of both the drug products and the types of tests and acceptance criteria..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=41)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...Development studies to investigate the potential effect of and the appropriateness of drug product acceptance.....Justification should be provided for all proposed acceptance criteria included in the drug product.....The specification establishes criteria to which each batch of drug product should conform to be considered acceptable for its..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=38)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...70, PET centers would have to ensure that each batch of PET drug product meets its established acceptance criteria, except.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface.....When the quality control unit has determined that a lot of material has met all acceptance criteria..
http://www.fda.gov/cder/guidance/4259dft.htm (score=35)

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.....In addition to toxicological considerations, justification of acceptance criteria for the drug substance impurities.....The guidance sets forth information that should be provided to ensure continuing drug product..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=34)

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.....In addition to toxicological considerations, justification of acceptance criteria for the drug substance impurities.....The guidance sets forth information that should be provided to ensure continuing drug product..
http://www.fda.gov/cder/guidance/2180dft.htm (score=34)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....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=34)

...1 Components of the Drug Product 5 2.1.1 Drug Substance 5 2.1.2 Excipients 5 2.2 Drug Product 6.....A successful correlation can assist in the selection of appropriate dissolution acceptance criteria.....The knowledge gained from the studies investigating the potential effect of drug substance properties on drug product..
http://www.fda.gov/cder/guidance/6672dft.doc (score=34)

Draft Guidance: ICH Q5E: Comparability of Biotechnological/Biological...
...When evaluating both the test methods and acceptance criteria for the post-change product, it is important to consider the general.....The tests and analytical procedures chosen to define drug substance or drug product specifications alone are.....Based on this evaluation, acceptance criteria to define highly similar post-change product can be..
http://www.fda.gov/cber/gdlns/ichcompbio.htm (score=33)

ICH; Draft Guidance on Q8 Pharmaceutical Development
...The knowledge gained from the studies investigating the potential effect of drug substance properties on drug product.....A successful correlation can assist in the selection of appropriate dissolution acceptance criteria.....Any overages in the manufacture of the drug product, whether they appear in the final..
http://www.fda.gov/cber/gdlns/ichq8pharm.htm (score=32)

6672dft.doc
...appropriateness of the drug product acceptance criteria should be reported in this section.....identification of those attributes that are critical to the quality of the drug product, taking.....correlation can assist in the selection of appropriate dissolution acceptance criteria..
http://www.fda.gov/cder/guidance/6672dft.pdf (score=32)

International Conference on Harmonisation; Draft Guidance on Q8...
...appropriateness of the drug product acceptance criteria should be reported in this section.....identification of those attributes that are critical to the quality of the drug product, taking.....correlation can assist in the selection of appropriate dissolution acceptance criteria..
http://www.fda.gov/cber/gdlns/ichq8pharm.pdf (score=32)

6003dft.doc
...on this evaluation, acceptance criteria to define highly similar post-change product can.....changes and that no adverse impact on the quality, safety, or efficacy of the drug product.....contractual arrangement to produce the intermediates, drug substance, or drug product on..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=31)

Q8 Pharmaceutical Development
...The knowledge gained from the studies investigating the potential effect of drug substance properties on drug product.....A successful correlation can assist in the selection of appropriate dissolution acceptance criteria.....Chemical Substances describes some of the circumstances in which drug product studies are..
http://www.fda.gov/cder/guidance/6672.dft.htm (score=31)

International Conference on Harmonisation; Draft Guidance on Q5E...
...on this evaluation, acceptance criteria to define highly similar post-change product can.....changes and that no adverse impact on the quality, safety, or efficacy of the drug product.....contractual arrangement to produce the intermediates, drug substance, or drug product on..
http://www.fda.gov/cber/gdlns/ichcompbio.pdf (score=31)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...Drug product containers and closures play a critical role in assuring that the drug product.....acceptance criteria, and the course of action to be taken if test results fall outside of.....Quarantine areas should be set up to separate the incoming drug product, incoming cylinders and..
http://www.fda.gov/cder/dmpq/freshair.htm (score=30)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=29)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....such cases, alternate approaches, such as qualifying higher acceptance criteria for a.....Ordinarily, the approved expiration dating period for the drug product may be retained if the..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=28)

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