MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....An alternative approach may be used if such approach satisfies the requirements of the.....discuss significant departures from the approaches outlined in this guidance with the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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.....Documents produced for others, where appropriate, can be used to provide the documentation of compliance with.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface..
http://www.fda.gov/cder/guidance/4259dft.htm (score=98)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....used if such approach satisfies the requirements of the applicable statutes and.....errors and ensure that appropriate corrective action is taken to prevent their recurrence..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=97)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...These trials cannot be used by themselves to support licensure of a product.Studies conducted in normal volunteers are not included in.....entity or is produced by a novel process, and when drug development plans are unusually.....appropriate, immunoglobulin fragments and recombinant proteins derived from..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=94)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...It would be unrealistic to expect drug product GMP concepts to apply to the production of these.....a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....The producer of BPCs must recognize the need for appropriate evaluation, using appropriate standards and/or test..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=94)

Guidance for Industry
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purpose.....Because of potential toxicities, this approach may not be appropriate for some drugs nor.....In studies that compare the effects of a test agent with another drug, biological product..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=94)

þÿ
...same principles for evaluating solid state form can be used, when appropriate, for other types of.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....its specification and, therefore, can be used in the manufacture of a given drug product..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=93)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...description of the methods used, actual data from appropriate tests, and evidence of assay.....abbreviate testing and IND submission for a product or product series, the sponsor should.....Murphy, HFM-17, Center for Biologics Evaluation and Research, Food and Drug Administration..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=91)

...only a limited characterization of the processes used to prepare the product for their ability to remove.....Sponsors should study a number of separate product lots during drug development to demonstrate that a safe and.....Such data can be useful in choosing appropriate potency assays, as well as in evaluating..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=91)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and.....same areas used to produce the drug substance that is the subject of this application.....appropriate quality and purity of the starting materials, including the seed organisms..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=90)

þÿ
...same principles for evaluating solid state form can be used, when appropriate, for other types of.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....its specification and, therefore, can be used in the manufacture of a given drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=89)

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
...An alternative approach may be used if such..approach satisfies the requirements of the.....This draft guidance, when finalized, will represent the Food and Drug Administration=s.....product-related frequencies, and severity with a view to taking additional, 1360.. and if..
http://www.fda.gov/cder/guidance/4011dft.pdf (score=85)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...product may be required as appropriate, depending on the final form and intended use of.....including the data from the material used to prepare clinical/pre-clinical lots and.....address during the investigation of a new animal drug and preparation of an..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=83)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...product may be required as appropriate, depending on the final form and intended use of.....including the data from the material used to prepare clinical/pre-clinical lots and.....address during the investigation of a new animal drug and preparation of an..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=83)

ICH: Guidance on Viral Safety Eveluation of Biotechnology Products Derived...
...and for the removal of virus from product, acceptable level of safety in the final product.....used in the context of the understanding of the biology of the virus and the nature of the.....5 As appropriate for cell lines which are known to have been infected by such agents.6 For..
http://www.fda.gov/cber/gdlns/virsafe.pdf (score=83)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug.....relation to the amount of crude product, whether it is filtered while hot, whether a.....Precautions, including animal safety testing when appropriate, to detect, identify, and..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=81)

...To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....The type of bioavailability study that is appropriate for a specific botanical drug.....A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=79)

Pediatric Rule
...In the development of a new drug or biological product, decisions about appropriate populations to study and.....that are dangerous to health when used in the manner prescribed, recommended, or suggested.....inadequate dosage or regimen, prescribed a less effective drug, or did not prescribe a drug, due to the physician's..
http://www.fda.gov/cder/guidance/pedrule.pdf (score=78)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....appropriate for a drug product with respect to the likelihood that such a design would.....and the test methods used to monitor the stability of the drug product packaged in the..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=76)

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug...
...2 The term drug substance, which is used throughout the text, is intended to include biological products as defined.....impurities during purification of the mAb may be appropriate under certain circumstances.....specificity, avidity,microbiological safety), appropriate product comparability testing should be..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=74)

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