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.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....2 The general term product as used in this guidance means drug substance, drug product, and intermediate.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=48)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....2 The general term product as used in this guidance means drug substance, drug product, and intermediate.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=46)

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.....When the quality control unit has determined that a lot of material has met all acceptance criteria.....71 would require a PET center to reject PET drug products that fail to meet acceptance..
http://www.fda.gov/cder/guidance/4259dft.htm (score=40)

Draft Guidance: ICH Q5E: Comparability of Biotechnological/Biological...
...Based on this evaluation, acceptance criteria to define highly similar post-change product can be.....The tests and analytical procedures chosen to define drug substance or drug product specifications alone are.....The comparison of the results to the predefined acceptance criteria allows an objective assessment of..
http://www.fda.gov/cber/gdlns/ichcompbio.htm (score=39)

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=37)

6003dft.doc
...on this evaluation, acceptance criteria to define highly similar post-change product can.....contractual arrangement to produce the intermediates, drug substance, or drug product on.....changes and that no adverse impact on the quality, safety, or efficacy of the drug product..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=36)

International Conference on Harmonisation; Draft Guidance on Q5E...
...on this evaluation, acceptance criteria to define highly similar post-change product can.....contractual arrangement to produce the intermediates, drug substance, or drug product on.....changes and that no adverse impact on the quality, safety, or efficacy of the drug product..
http://www.fda.gov/cber/gdlns/ichcompbio.pdf (score=36)

Guidance- Content & Format CMC for Vaccine & Related Product
...new lots of reference standards and acceptance criteria for a new reference standard.....A list should be provided of all components in the drug product, including drug substance(s)and other ingredients.....trials materials and commercial production batches of drug substance and drug product..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=34)

ANDAs: Impurities in Drug Substances
...In other words, where there is no safety concern,impurity acceptance criteria should be based on data.....In summary, the drug substance acceptance criteria should include, where applicable.....Conformance to specifications means that the drug substance and/or drug product, when..
http://www.fda.gov/cder/guidance/2452fnl.pdf (score=32)

ANDAs: Impurities in Drug Substances, Guidance Document
...In summary, the drug substance acceptance criteria should include, where applicable, acceptance criteria.....Acceptance criteria should be based on pharmacopeial standards or known safety data, taking.....It establishes the set of criteria to which a drug substance or drug product should conform to be considered..
http://www.fda.gov/cder/guidance/2452fnl.htm (score=31)

...This can be accomplished by examining and/or testing to ensure that the acceptance criteria are met.....Additional criteria and procedures by which a botanical drug substance may become eligible for inclusion in the OTC drug monograph.....Appropriate acceptance specifications established by the botanical drug product..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=30)

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...adequate acceptance criteria to ensure that batches of drug products meet each appropriate.....1 This guidance has been prepared by the Inhalation Drug Products LDPE Working Group of.....specification and appropriate statistical quality control criteria as a condition for..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=30)

ANDAs: Impurities in Drug Substances
...Listing of impurities and Setting Acceptance Criteria for Impurities in Drug substance Specifications.....The guidance also provides recommendations for establishing acceptance criteria for impurities in.....Listing of impurities and Setting Acceptance Criteria for Impurities in Drug substance Specifications..
http://www.fda.gov/cder/guidance/6422dft.htm (score=29)

Chem Revs. of DMFs for DSIs
...and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances International Conference on.....the bioavailability of the drug products made from the substance, including, for example.....appropriate acceptance criteria that are numerical limits, ranges, or other..criteria for the tests..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=28)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...Assessment of stability typically includes assaying each active ingredient to meet acceptance.....This evaluation provides the link between the new combination drug product and the drug products whose safety.....Acceptance criteria for process impurities and degradants should be set based on manufacturing..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=27)

Tamiflu NDA 21-246
...Reassess the acceptance criteria for degradants in the drug product specification when the.....demonstrate that the drug product is safe and effective for use as recommended in the.....the proposed acceptance criteria, through a prior approval supplement. Supplement..
http://www.fda.gov/cder/foi/appletter/2000/21246ltr.pdf (score=27)

Guidance for Industry: Q3A Impurities in New Drug Substances
...provide a rationale for establishing impurity acceptance criteria that includes safety considerations.....This guidance is not intended to apply to new drug substances used during the clinical.....Acceptance criteria should be set no higher than the level that can be justified by safety..
http://www.fda.gov/cber/gdlns/ichq3a.pdf (score=27)

stability guidance -draft
...such cases, alternate approaches, such as qualifying higher acceptance criteria for a.....this guidance to mean a batch of drug substance or drug product manufactured at the scale typically.....If the stability data under the ICH conditions fall outside the acceptance criteria while..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=27)

ICH; Guidance for Industry: Q3A Impurities in New Drug Substances
...Acceptance criteria and analytical procedures used to estimate identified or unidentified impurities.....An impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance.....Those individual impurities with specific acceptance criteria included in the specification for a new..
http://www.fda.gov/cber/gdlns/ichq3a.htm (score=27)

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