MDI and DPI Drug Products
...discuss significant departures from the approaches outlined in this guidance with the.....considerations, justification of acceptance criteria for the drug substance impurities.....A description of in-process controls, analytical tests, and appropriate data to support..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...Appropriate acceptance specifications established by the botanical drug product manufacturer for the.....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.doc (score=28)

Guidance for Industry Botanical Drug Products
...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.....Nonclinical evaluation to characterize toxicities may be appropriate for products with..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=15)

...If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....Appropriate acceptance factors should be established and justified. When a novel or non-novel but non.....Dissolution Method For novel dosage forms, an appropriate in vitro release test method..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0206-gdl0001.doc (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)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and tests should be instituted to control those drug substance.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria.....Appropriate acceptance criteria and validated test methods should be established for each test..
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.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria.....Appropriate acceptance criteria and validated test methods should be established for each test..
http://www.fda.gov/cder/guidance/2180dft.htm (score=15)

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=9)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...When the quality control unit has determined that a lot of material has met all acceptance.....If appropriate, this draft guidance will be revised and republished for comment in.....The batch record also should contain a compilation of tests and printouts that led to..
http://www.fda.gov/cder/guidance/4259dft.htm (score=9)

Sterile Drug Products Produced by Aseptic Processing
...There should be written procedures and appropriate specifications for acceptance or rejection of each lot of components.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....bioburden, endotoxin) of each component that could be contaminated and establish appropriate..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=9)

Guidance for Industry
...appropriate specifications for acceptance or rejection of each lot of components that.....appropriate written specifications for the acceptance of each lot within each shipment of.....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)

Guidance for Industry
...appropriate specifications for acceptance or rejection of each lot of components that.....appropriate written specifications for the acceptance of each lot within each shipment of.....regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=9)

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.....Shelf-Life Acceptance Criteria The concept of different acceptance criteria for release vs.....Where harmonization has been achieved, an appropriate reference to the harmonized..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=9)

CGMP Regulations
...The statistical quality control criteria shall include appropriate acceptance levels and/or.....Prior to acceptance and use, reprocessed material must meet appropriate standards.....In such instances a written record of the program shall be maintained along with..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=9)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...procedures and acceptance criteria which, stability of drug substance and drug product. A.....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..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=9)

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...extract drug products currently are not likely to be appropriate subjects for abbreviated.....The clinical studies confirming efficacy of the specific PEP should include appropriate.....Appropriate.. 140.. acceptance factors should be established and justified. When a novel or non-novel but non..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0206-gdl0001.pdf (score=9)

...A list of tests, references to analytical procedures, and appropriate acceptance criteria which are.....Contaminants should be strictly avoided and/or suitably controlled with appropriate in-process acceptance.....Individual and/or collective acceptance criteria for impurities should be set, as..
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)

CBER Letter - Consent Decree Notification - Parkedale Pharmaceuticals Inc.
...The acceptance of the lot was based partially on the "nature of product to have temporary.....FDA is concerned because Parkedale failed to recognize, investigate, and take appropriate.....acceptance, of certain actions described in detail below. As you know, this is the third..
http://www.fda.gov/cber/ltr/park031000.htm (score=9)

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

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