...FDA will maintain a requirement for reporting data from all ongoing product stability studies.....Name of the applicant, application number, product name, dosage form, product use category, type of study, commitment.....FDA's current guidance for industry states that data accumulated from ongoing stability..
http://www.fda.gov/OHRMS/DOCKETS/98fr/103000c.htm (score=100)

HUMAN DRUG CGMP NOTES March 1998
...For example, microbial content that adversely affects product stability, would be.....This means that even though a drug product is not sterile, a firm must follow written.....On Stability (Questions on drug product stability) Should a manufacturer be cited on an FDA-483 for CGMP violations on the part..
http://www.fda.gov/cder/hdn/cnotes38.htm (score=77)

HUMAN DRUG CGMP NOTES, June 1997
...Because in large containers dosage units near the closure may have different stability.....The nature and extent of end product testing beyond potency should be determined by the.....On May 11, 1995, the agency concurred with the CGA based on the amounts of product loss..
http://www.fda.gov/cder/hdn/cnotes67.htm (score=76)

CBER - Withdrawal of Antihemophilic Factor (Recombinant)
...Bayer Corporation discovered during the monitoring of product stability for potency on lot 670H076.....Potency continues to remain stable when the product is stored under refrigeration (2-8C.....PRODUCT / LOT NUMBER / EXPIRATION DATE: Antihemophilic Factor (Recombinant), Kogenate..
http://www.fda.gov/cber/recalls/bayahf072700.htm (score=76)

Guidanc for Industry: Container and Closure Integrity Testing in Lieu of...
...testing of drugs, and provides a general indication of the information on product.....assessment of continuing sterility are accepted in the stability program for pending new.....than sterility testing to confirm container and closure integrity as a part of stability..
http://www.fda.gov/cber/gdlns/contain.pdf (score=55)

Reporting Adverse Reactions and Other Product Problems
...Yet some problems can remain unknown, only to be discovered when a product is used by a.....Describe the product as completely as possible, including any codes or identifying marks.....product stability. Other Products.. Vaccines--Adverse reactions and other problems related to..
http://www.fda.gov/fdac/features/1998/698_mail.html (score=55)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...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.....conditions and verification of its stability under the conditions described should be.....field trials will be obtained prior to submission of a product application, APHIS/BRS will..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=54)

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.....conditions and verification of its stability under the conditions described should be.....field trials will be obtained prior to submission of a product application, APHIS/BRS will..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=54)

ICH; Guidance for Industry Q1D Bracketing and Matrixing Designs for...
...Data variability and product stability, as shown by supporting data, should be considered when a.....When a secondary packaging system contributes to the stability of the drug product, matrixing can be performed.....The design assumes that the stability of each subset of samples tested represents the..
http://www.fda.gov/cber/gdlns/ichq1d.htm (score=54)

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...variability and product stability, as shown by supporting data, should be considered when.....When a secondary packaging system contributes to the stability of the drug product.....that the stability of any intermediate levels is represented by the stability of the..
http://www.fda.gov/cber/gdlns/ichq1d.pdf (score=54)

BIOTECHNOLOGY INSPECTION GUIDE
...Another concern about product stability is the use of inert gas to displace oxygen during both the.....One important aspect of an inspection is to identify defective product, non-conforming product and system failures.....Because genetic stability of the cell bank during storage and propagation is a major..
http://www.fda.gov/ora/inspect_ref/igs/biotech.html (score=54)

...Since an ANDA applicant must demonstrate that the generic drug product exhibits adequate.....In particular, inadvertent changes to the polymorphic form that may affect drug product BA/BE can often be detected by drug product.....The extent of conversion generally depends on the relative stability of the polymorphs..
http://www.fda.gov/cder/guidance/6154dft.doc (score=54)

Draft Guidance for Industry: Cooperative Manufacturing Arrangements for...
...manufacture a biological product on the basis of a demonstration that the biological.....the intermediate products, the ability of the manufacturers to demonstrate the stability.....product to occur, since determining the approvability of the product to be licensed will..
http://www.fda.gov/cber/gdlns/coopmfr.pdf (score=53)

Scientific Positions within Office of Pharmaceutical Science
...They serve as consultants to all fifteen medical divisions in the CDER in the review of.....product stability information. In addition to this review role, the Office of Testing and Research.....Serve as a resource for microbiological attributes of product quality as they relate to..
http://www.fda.gov/cder/OPS/positions.htm (score=53)

CBER - Impact of Severe Weather Conditions on Biological Products
...Most vaccine manufacturers have filed data with CBER to support the stability of their.....People should not be put at risk by using a product that may be unsafe due to the.....Most biological products require specific storage conditions, as indicated in the product..
http://www.fda.gov/cber/weatherimpact.htm (score=53)

MDI and DPI Drug Products
...manufacturing, processing, packaging, controls, stability testing, or labeling operations.....The guidance sets forth information that should be provided to ensure continuing drug.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=34)

6003dft.doc
...therefore, real-time concurrent stability studies on the product potentially affected by.....evaluated for its impact on stability, since proteins are frequently sensitive to changes.....generally evaluates the quality attributes of the product to demonstrate that..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=33)

...Biological Product Stability Provide a description of the storage conditions, study protocols and.....The proposed shelf life of the biological product should be stated and the data for.....Thus, the set of tests chosen will vary from product to product, and should be guided by preclinical..
http://www.fda.gov/cber/gdlns/xvcmc.txt (score=32)

GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS
...The manufacturer's data for the establishment of moisture specifications for both product release and.....The free water in a product is that water that is absorbed on the surfaces of the product.....Additionally, inspections have disclosed potency, sterility and stability problems..
http://www.fda.gov/ora/inspect_ref/igs/lyophi.html (score=32)

/a//content.14388
...Mixing, granulating, milling, molding, of components, drug product containers, formulating.....whether they use terminal sterilization, three initial batches in the stability.. Sampling.....components, drug product containers, may have an impact on drug product.. size to provide..
http://www.fda.gov/cder/dmpq/fr5396.pdf (score=32)

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