MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....discuss significant departures from the approaches outlined in this guidance with the.....considerations, justification of acceptance criteria for the drug substance impurities..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...This can be accomplished by examining and/or testing to ensure that the acceptance criteria are met.....Appropriate acceptance specifications established by the botanical drug product.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=27)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and tests should be instituted to control those drug substance parameters.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on.....Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation using a..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=15)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and tests should be instituted to control those drug substance parameters.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on.....Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation using a..
http://www.fda.gov/cder/guidance/2180dft.htm (score=15)

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...adequate acceptance criteria to ensure that batches of drug products meet each appropriate.....specification and appropriate statistical quality control criteria as a condition for.....laminate and application of appropriate acceptance criteria (e.g., thickness of aluminum..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=15)

Guidance for Industry Botanical Drug Products
...appropriate acceptance criteria for batch release need not be established until later in phase 3.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....However, the sponsor relying on information in a DMF should have adequate acceptance..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=14)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...procedures and acceptance criteria which, stability of drug substance and drug product. A qualitative.....be minimized by the use of appropriate, well- characterization of the product as described.....A specification is defined as a list of tests, Acceptance Criteria for.. The text of the guidance..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=11)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical.....Shelf-Life Acceptance Criteria 2.3 In-Process Tests 2.4 Design and Development Considerations 2.5.....Where harmonization has been achieved, an appropriate reference to the harmonized..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=11)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...When the quality control unit has determined that a lot of material has met all acceptance criteria.....If appropriate, this draft guidance will be revised and republished for comment in.....When it is determined that all acceptance criteria have been met, the PET center should then provide..
http://www.fda.gov/cder/guidance/4259dft.htm (score=10)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....errors and ensure that appropriate corrective action is taken to prevent their recurrence.....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=10)

...A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical.....Contaminants should be strictly avoided and/or suitably controlled with appropriate in-process acceptance criteria or action.....2 In-process Acceptance Criteria and Action Limits 2.3.3 Raw Materials and Excipient Specifications 2..
http://www.fda.gov/cber/gdlns/ichtest.txt (score=9)

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...appropriate acceptance criteria which are numerical limits, ranges, or other criteria for.....acceptance criteria, the value of this guidance is linked to the extent of harmonization.....and biological product and should be determined using an appropriate assay,usually..
http://www.fda.gov/cder/guidance/Q6Bfnl.PDF (score=9)

ANDAs: Impurities in Drug Substances, Guidance Document
...A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical.....In summary, the drug substance acceptance criteria should include, where applicable, acceptance.....Because these are generally of known toxicity, the selection of appropriate controls is..
http://www.fda.gov/cder/guidance/2452fnl.htm (score=9)

ANDAs: Impurities in Drug Substances
...In other words, where there is no safety concern,impurity acceptance criteria should be based on data.....these are generally of known toxicity, the selection of appropriate controls is easily.....If data are unavailable to qualify the proposed acceptance criteria of an impurity, studies to obtain..
http://www.fda.gov/cder/guidance/2452fnl.pdf (score=9)

Chem Revs. of DMFs for DSIs
...and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances.....For additional guidance please refer to appropriate CDER guidance documents concerning.....appropriate acceptance criteria that are numerical limits, ranges, or other..criteria for the tests..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=9)

Guidance for Industry
...regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic.....preparation of rubber stoppers should meet appropriate quality control criteria and not.....appropriate specifications for acceptance or rejection of each lot of components that..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=8)

Guidance for Industry
...regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic.....preparation of rubber stoppers should meet appropriate quality control criteria and not.....appropriate specifications for acceptance or rejection of each lot of components that..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=8)

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...adequate acceptance criteria to ensure that batches of drug products meet each appropriate.....specification and appropriate statistical quality control criteria as a condition for.....laminate and application of appropriate acceptance criteria (e.g., thickness of aluminum..
http://www.fda.gov/cder/guidance/4168dft.PDF (score=8)

Sterile Drug Products Produced by Aseptic Processing
...Silicone used in the preparation of rubber stoppers should meet appropriate quality control criteria and not have an.....There should be written procedures and appropriate specifications for acceptance or rejection of each lot of components.....Design of a given area involves satisfying microbiological and particle criteria as..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=8)

CGMP Regulations
...The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection.....Prior to acceptance and use, reprocessed material must meet appropriate standards.....appropriate criteria such as statistical criteria for component variability, confidence levels, and..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=8)

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