...A status report of each postmarketing study of the drug product concerning clinical safety.....FDA will maintain a requirement for reporting data from all ongoing product stability studies.....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
...This means that even though a drug product is not sterile, a firm must follow written.....For example, microbial content that adversely affects product stability, would be.....Therefore, a quality control unit could be a corporation external to the drug product..
http://www.fda.gov/cder/hdn/cnotes38.htm (score=78)

HUMAN DRUG CGMP NOTES, June 1997
...Because in large containers dosage units near the closure may have different stability.....Welcome to another edition of Human Drug CGMP Notes, our periodic memo on CGMP for human.....The nature and extent of end product testing beyond potency should be determined by the..
http://www.fda.gov/cder/hdn/cnotes67.htm (score=77)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...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.....address during the investigation of a new animal drug and preparation of an.....conditions and verification of its stability under the conditions described should be..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (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Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...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.....address during the investigation of a new animal drug and preparation of an.....conditions and verification of its stability under the conditions described should be..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=55)

Guidance for Industry - Content and Format of Chemistry, Manufacturing and...
...If the drug product is frozen, data supporting the stability of the product through a stated.....This section should contain information on the final drug product including all drug substances.....the evidence derived from validation studies which assures that product identity, purity, potency, and stability is preserved for..
http://www.fda.gov/cber/gdlns/cmcvacc.htm (score=53)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=34)

/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.....Therefore, under the Federal Food, all established standards, specifications, Drug, and..
http://www.fda.gov/cder/dmpq/fr5396.pdf (score=33)

Human Drug Notes
...65 require that equipment used in processing of a drug product be suitable for its intended use.....In the latter case, until appropriate stability data is generated, the expiration date.....drug product, stability studies should be conducted according to an approved stability protocol..
http://www.fda.gov/cder/hdn/hdn1295.htm (score=33)

Human Drug Notes
...While the expiration dating assigned to such products would be based on the stability of the drug product, stability.....The retention time is at least one year after the expiration date of the drug product, or, in.....Stability/Expiration Dates Barry Rothman 594-0098 Sterile Facility Construction (Clean..
http://www.fda.gov/cder/hdn/hdn995.htm (score=33)

GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS
...Excessive temperatures may cause physical and/or chemical degradation of the drug product.....In addition, preservative effectiveness must be monitored as part of the final on-going.....The subjects covered in the guide are generally applicable to all forms of topical drug..
http://www.fda.gov/ora/inspect_ref/igs/topic.html (score=33)

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...No clinically significant drug-drug interactions between itraconazole, theophylline, warfarin.....The potential for pharmacokinetic drug interactions between moxifloxacin and itraconazole.....The color does not affect, nor is it indicative of, product stability. The inactive.. 25..
http://www.fda.gov/cder/foi/label/2002/21085s6s7lbl.pdf (score=31)

Human Drug Notes
...396 10 HUMAN DRUG CGMP NOTES March 1996 DIVISION OF MANUFACTURING AND PRODUCT QUALITY, HFD.....Where an expiration dating period is derived from stability studies conducted on the.....Levchuk 594-0095 12 HUMAN DRUG CGMP NOTES March 1996 DIVISION OF MANUFACTURING AND PRODUCT..
http://www.fda.gov/cder/hdn/hdn396.htm (score=12)

HUMAN DRUG CGMP NOTES June 1998
...FOR EACH BATCH OF DRUG PRODUCT, there shall be appropriate laboratory determination of.....166, Stability testing, and 211.167, Special testing requirements; Compliance Policy Guide.....If that were true then there should never be any batch failures or drug product recalls, and we..
http://www.fda.gov/cder/hdn/cnotes68.htm (score=11)

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.....This evaluation provides the link between the new combination drug product and the drug..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=11)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...It would be unrealistic to expect drug product GMP concepts to apply to the production of these.....This, together with the generally widespread existence of stability testing programs, make.....It has been demonstrated that impurities in a finished drug product can cause degradation and..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=11)

HUMAN DRUG CGMP NOTES September 1999
...As explained in the stability guideline, the expiration date assigned to a new lot of.....Welcome to another edition of Human Drug CGMP Notes, our periodic guidance memo for FDA.....3-A Accepted Practices for Permanently Installed Sanitary Product Pipelines and Cleaning..
http://www.fda.gov/cder/hdn/cnotes99.htm (score=11)

Packaging
...It should provide an adequate seal, be compatible with the drug product, and not be a source of.....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 container/clsoure system in which..
http://www.fda.gov/cder/guidance/package.htm (score=11)

7356-002-Draft: DRUG MANUFACTURING INSPECTIONS (Pilot Program)
...The health significance of certain CGMP deviations may be lower when the drug product involved.....stability testing program, including demonstration of stability indicating capability of.....It includes all product defect evaluations and evaluation of returned and salvaged drug..
http://www.fda.gov/ora/cpgm/7356_002/7356-002-Draft.html (score=11)

Guidance for Industry
...ensuring that the drug product provided to the patient has the appropriate identity, strength.....provided that they meet appropriate standards or specifications as demonstrated by.....if the condition of the drug product, as a result of storage or shipping, casts doubt on the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=11)

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