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.....manufacturing, processing, packaging, controls, stability testing, or labeling operations..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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.....stability parameters include radiochemical identity and purity, appearance, pH, stabilizer..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=92)

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.....are used, master vector seed stocks should be generated, and the genetic stability of the.....entity or is produced by a novel process, and when drug development plans are unusually..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=92)

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.....protocol to be used, number of final lots to be entered into the stability protocol each.....This section should contain information on the final drug product including all drug substances..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=89)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...abbreviate testing and IND submission for a product or product series, the sponsor should.....Virus or DNA preparations used as preventive vaccines are not covered by this document.....Murphy, HFM-17, Center for Biologics Evaluation and Research, Food and Drug Administration..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=88)

...The conditions under which product stability is evaluated and the positive and negative controls.....Sponsors should study a number of separate product lots during drug development to demonstrate that a safe and.....The areas used for final fill of drug products should follow the recommendations provided in the "Guidelines on..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=88)

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...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.....should explain the scientific reasons why a stability indicating procedure is not viable..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=88)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Appropriate parameters should be evaluated to establish and document the stability of a PET drug product under.....Equipment used in the production, processing, or packaging of a PET drug product should be.....61 would require the establishment of a written stability testing program for each PET..
http://www.fda.gov/cder/guidance/4259dft.htm (score=88)

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.....This, together with the generally widespread existence of stability testing programs, make..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=88)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...information on the stability of the final product and any in-process material at each.....include the protocol to be used, number of final lots/serials to be entered into the.....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=86)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...information on the stability of the final product and any in-process material at each.....include the protocol to be used, number of final lots/serials to be entered into the.....address during the investigation of a new animal drug and preparation of an..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=86)

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...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.....should explain the scientific reasons why a stability indicating procedure is not viable..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=84)

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
...An alternative approach may be used if such..approach satisfies the requirements of the.....46 Stability testing of the final blended batches is necessary if the blending could.. 812.....This draft guidance, when finalized, will represent the Food and Drug Administration=s..
http://www.fda.gov/cder/guidance/4011dft.pdf (score=79)

stability guidance -draft
...Significant change for a drug product at the accelerated stability condition and the.....container and closure integrity testing may be used for other stability testing for that.....this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=77)

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.....demonstrating adequate product stability, bioavailability, and.. production process..
http://www.fda.gov/cder/guidance/pedrule.pdf (score=76)

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.....Stability.. The regulations require a full description of the stability of the drug..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=76)

...To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....The sponsor should develop stability-indicating analytical methods and conduct stability.....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=74)

Safety and Effectiveness of New Drugs & Biological Products in Pediatric...
...Where there is evidence that a drug product is widely used in pediatric patients, failure to provide adequate.....The need for studies in more than one age group would depend on whether the drug or biological product was likely to be used in each.....product stability, bioavailability, and production process validation. While such costs would vary..
http://www.fda.gov/cder/guidance/pedrule.htm (score=73)

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.....The mAb manufacturer should perform real-time stability studies of unconjugated and.....specificity, avidity,microbiological safety), appropriate product comparability testing..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=69)

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