MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....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)

...Appropriate acceptance specifications established by the botanical drug product manufacturer for the.....These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....The type of bioavailability study that is appropriate for a specific botanical drug..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=28)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Equipment used in the production, processing, or packaging of a PET drug product should be appropriate for the.....70, PET centers would have to ensure that each batch of PET drug product meets its established acceptance criteria, except.....The proposed regulation would require the implementation of procedures to ensure that a product is not released until..
http://www.fda.gov/cder/guidance/4259dft.htm (score=18)

þÿ
...system components are critical to ensure the quality and purity of the drug product and must be.....adequate acceptance criteria to ensure that batches of drug products meet each appropriate.....specification and appropriate statistical quality control criteria as a condition for..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=17)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....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=17)

...Drug Product Specifications for the drug product should include tests for identity, biological activity of different classes of.....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..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0206-gdl0001.doc (score=16)

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.....Appropriate acceptance criteria should be instituted for the appearance of the drug.....Appropriate acceptance criteria and tests should be instituted to control those drug..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=15)

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.....Appropriate acceptance criteria should be instituted for the appearance of the drug.....Appropriate acceptance criteria and tests should be instituted to control those drug..
http://www.fda.gov/cder/guidance/2180dft.htm (score=15)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...Cell substrate-derived, employed will vary from product to product, structure of the carbohydrate.....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..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=14)

...In some cases, testing at production stages rather than testing at the finished drug substance or drug product stages may be.....A list of tests, references to analytical procedures, and appropriate acceptance criteria which are.....2 Drug Product Specification Generally, the following tests and acceptance criteria are..
http://www.fda.gov/cber/gdlns/ichtest.txt (score=14)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....appropriate specifications for acceptance or rejection of each lot of components that.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=13)

Sterile Drug Products Produced by Aseptic Processing
...Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design.....There should be written procedures and appropriate specifications for acceptance or rejection of each lot of components.....For each batch of drug product purporting to be sterile and/or pyrogen free, there shall be..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=13)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....appropriate specifications for acceptance or rejection of each lot of components that.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=12)

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.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=12)

CGMP Regulations
...A drug product may be reprocessed provided the subsequent drug product meets appropriate standards.....The statistical quality control criteria shall include appropriate acceptance levels and/or.....Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=10)

þÿ
...system components are critical to ensure the quality and purity of the drug product and must be.....adequate acceptance criteria to ensure that batches of drug products meet each appropriate.....specification and appropriate statistical quality control criteria as a condition for..
http://www.fda.gov/cder/guidance/4168dft.PDF (score=10)

þÿ
...For a pancrelipase or pancreatin product to be approved as an ANDA, the proposed drug.....The clinical studies confirming efficacy of the specific PEP should include appropriate.....compendial excipient is included in the formulation of the drug product, manufacturing and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0206-gdl0001.pdf (score=10)

Chem Revs. of DMFs for DSIs
...and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances International Conference on.....For additional guidance please refer to appropriate CDER guidance documents concerning.....If a drug product available for oral use is then submitted as an..ophthalmic product..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=9)

Exocrine Pancreatic Insufficiency Drug Products -
...For a pancrelipase or pancreatin product to be approved as an ANDA, the proposed drug product.....4 For the reasons described below, the Agency has determined that pancreatic extract drug products currently are not likely to be.....Appropriate acceptance factors should be established and justified. When a novel or non-novel but non..
http://www.fda.gov/cder/guidance/5064dft.htm (score=9)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...10 Impact of Drug Substance on Drug Product Specifications In general, it should not be necessary to test the.....A list of tests, references to analytical procedures, and appropriate acceptance criteria that are.....It establishes the set of criteria to which a drug substance or drug product should conform to be considered..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=9)

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