Guidance for Industry - Cooperative Manufacturing Arrangements for Licensed...
...Restricting issuance of biological product licenses solely to companies performing all.....product stability studies, complaint handling, recalls, error and accident reporting, and adverse.....stability of the intermediate product during shipment, the adequacy of intermediate and..
http://www.fda.gov/cber/gdlns/coopmfr.htm (score=100)

Draft Guidance for Industry: Cooperative Manufacturing Arrangements for...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=100)

ENFORCEMENT REPORT FOR MARCH 24, 1999
...Product contains hazelnuts, but does not declare this ingredient in the statement of.....Stability - Product may not maintain potency for the labeled expiration date due to.....Dissolution failure at 18 month stability testing. RECALLS AND FIELD CORRECTIONS..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00582.html (score=100)

ENFORCEMENT REPORT FOR April 14, 1999
...PRODUCT Lyophilized Rx antibiotics for injection packaged in single dose ADD-Vantage vials.....REASON Stability - Product may not maintain ethanol levels within specification prior to.....The holding carton is correctly labeled as Genatap liquid and the product in the bottle is..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00585.html (score=100)

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=37)

Federal Register: August 14, 1997 (Volume 62, Number 157
...The recall was initiated when the product was found to be below potency at 18-month.....There is new information showing significant stability and potency problems with orally.....A citizen petition claiming that a particular drug product is not subject to the new drug..
http://www.fda.gov/cder/fedreg/fr14au97-83.htm (score=36)

þÿ
...dissolution or bioavailability of the drug product, and further studies on the drug.....should explain the scientific reasons why a stability indicating procedure is not viable.....Stability data to support holding times for intermediates or during processing should also..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=35)

þÿ
...dissolution or bioavailability of the drug product, and further studies on the drug.....should explain the scientific reasons why a stability indicating procedure is not viable.....Stability data to support holding times for intermediates or during processing should also..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=34)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...15 Sponsors should evaluate the stability of the drug product in the actual dispensing package as well as in any.....Sponsors should evaluate the stability of the drug product in the actual dispensing package as well as in any.....The dissolution method should be incorporated into the stability and quality control..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=34)

Guidance for Industry
...The new information needed to support blister packaging would typically be limited to.....2 For the purposes of this guidance, a co-packaged product consists of two or more.....available long-term stability data,14 plus short-term stress studies under high..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf (score=33)

Microsoft Word - 5320.1.doc
...Description of the Composition of the Drug Product..Description of the drug product.....2 Post-Approval Stability Protocol and Stability Commitment.. Analytical procedures and testing schedule for.....shows the location for product quality microbiology..information submitted in the CTD-Q..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=33)

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)

Microsoft Word - 5020.1.doc
...Description of the Composition of the Drug Product..Description of the drug product.....2 Post-Approval Stability Protocol and Stability Commitment.. Analytical procedures and testing schedule for.....shows the location for product quality microbiology..information submitted in the CTD-Q..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=33)

Packaging
...This information should include the proposed market package for the product and the relevant stability and.....Samples of a drug that are selected for stability studies should be packaged in the.....It should provide an adequate seal, be compatible with the drug product, and not be a..
http://www.fda.gov/cder/guidance/package.htm (score=33)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...For example, where the product is marketed in polylined drums, it is acceptable to keep.....This, together with the generally widespread existence of stability testing programs, make.....It would be unrealistic to expect drug product GMP concepts to apply to the production of..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=33)

Guidance for Industry
...usually contain a residual product and a commingling of new and old product would result.....provided that they meet appropriate standards or specifications as demonstrated by.....There must be a written testing program designed to assess the stability characteristics..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=33)

7356-002-Draft: DRUG MANUFACTURING INSPECTIONS (Pilot Program)
...stability testing program, including demonstration of stability indicating capability of.....It includes all product defect evaluations and evaluation of returned and salvaged drug.....firm's stability testing program, including demonstration of stability indicating..
http://www.fda.gov/ora/cpgm/7356_002/7356-002-Draft.html (score=33)

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=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=33)

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=33)

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