CBER Approval Letter - Anthrax Vaccine Adsorbed (BioThrax), BioPort Corp
...Under this approval, the dating period for final container product will be 36 months when the.....Product Approval Information - Licensing Action.. DEPARTMENT OF HEALTH AND HUMAN SERVICES..
http://www.fda.gov/cber/approvltr/biopava042705L.htm (score=100)

Klein's Naturals Fruity Deluxe Dried Fruit Mix Recalled Due to Undeclared...
...packages of Klein's Naturals Fruity Deluxe dried fruit mix, because the product contains.....container. Product was distributed in the New York and New Jersey. The recall was.....FDA does not endorse either the product or the company. Klein's Naturals Fruity Deluxe..
http://www.fda.gov/oc/po/firmrecalls/kleins03_02.html (score=53)

ORA/OE/DCMO - C. botulinum Recall Press Release
...Product was distributed List of states and areas where the product was distributed and how.....type of container [plastic/metal/glass], size and appearance of container, product brand.....Company Name of City, State is recalling Quantity and/or type of Product, because it has..
http://www.fda.gov/ora/compliance_ref/recalls/botulism.htm (score=38)

ICH: Final Guideline on Stability Testing of Biotechnological/Biological...
...the product retains its full potency, purity, biotechnological/biological products but are.....batches of final container product included.. characteristics to which consideration.....container product placed on stability studies.. biological activity, where applicable..
http://www.fda.gov/cber/gdlns/ichq5c071096.pdf (score=37)

ichq5c
...Where possible,batches of final container product included in stability testing should be derived.....Where pilot-plant scale batches were submitted to establish the dating for a product and,in the event that the product.....constructed of the same material and use the same type of container/closure system that is..
http://www.fda.gov/cder/guidance/ichq5c.pdf (score=37)

...Where possible, batches of final container product included in stability testing should be derived.....The quality of the final container product placed on stability studies should be representative of.....5 Container/Closure Changes in the quality of the product may occur due to the..
http://www.fda.gov/cber/gdlns/ichq5c071096.txt (score=37)

SBA - Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method...
...It is noted, however, that the final container product may contain traces of murine MAb.....Assays of the drug substance and drug product have been validated for accuracy, precision.....potential loss of Factor VIII product to the patient. A bolus dose of ADVATE rAHF-PFM..
http://www.fda.gov/Cber/sba/antibax072503S.pdf (score=21)

...11, an amount of the final container product is injected into the peritoneum of guinea pigs and mice.....The comment noted that the amount of final container product administered to animals for the GST may.....Manufacturers wishing to obtain an exemption to the GST for a particular product would contact the appropriate product division..
http://www.fda.gov/cber/rules/gensafety.txt (score=21)

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM),...
...It is noted, however, that the final container product may contain traces of murine MAb from the.....The final drug product contains no preservatives, nor any added human or animal components.....The final product contains only trace amounts of rVWF, which will not have any clinically..
http://www.fda.gov/cber/sba/antibax072503S.htm (score=21)

/a//content.7520
...product is greatly reduced. protection of the public health. continues to serve as a.....introduced into the final container.. that the additional time needed to.. the aggregate.....The title, characterize the final product and.. agency believes that this direct final..
http://www.fda.gov/cber/rules/gensafety.pdf (score=21)

Guidance for the Evaluation of Combination Vaccines for Preventable...
...period be available from at least three lots of final container product covering the.....the suitability of the container and closure for the combination product should be.....as a lyophilized product, demonstration of the potency of the product in the final..
http://www.fda.gov/cber/gdlns/combvacc.pdf (score=21)

...An example might be an adsorbed product, or a product that is difficult to resuspend, where the final.....Identity tests should focus on those differences that exist between different final.....The lots of monovalent product selected for the combination product should represent normal manufacturing lots and should be..
http://www.fda.gov/cber/gdlns/combvacc.txt (score=21)

Acidified food manufacturers
...All records must contain enough additional information such as product name, product code, date, and container size to permit.....Are container examinations made as per the container manufacturer specifications and or.....Any non-standardized products labeled using these terms must conform to certain product..
http://www.fda.gov/ora/inspect_ref/igs/acidfgde.htm (score=8)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....The guidance sets forth information that should be provided to ensure continuing drug.....elastomeric, plastic components or coatings of the container and closure system when in..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=8)

...This 6 would provide an easily recognizable/legible symbol 7 on the container that would represent a product 8 type, for.....area, fills 2 the container, and it withdraws, and then the 3 container is sealed and.....Unlike 17 issues before a committee in which a particular 18 product is discussed, issues..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=8)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....It is also possible for a component of the drug product to migrate through the walls of the container, and oxygen, carbon dioxide, or.....A suitable closure is an essential part of the container/closure system required to..
http://www.fda.gov/cder/guidance/package.htm (score=8)

Guidance for Industry
...oxygen container, installed it on the argon container, and connected the deadly product to.....container and attached it to the container containing argon, and was able to fill the.....usually contain a residual product and a commingling of new and old product would result..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=8)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is.....In an aseptic process, the drug product, container, and closure are first subjected to.....could increase the potential for introducing contaminants to exposed product, container-closures..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=7)

Microsoft Word - 5320.1.doc
...Description of the Composition of the Drug Product..Description of the drug product.....Container Closure System..Description of the container-closure system used for the drug.....shows the location for product quality microbiology..information submitted in the CTD-Q..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=7)

Microsoft Word - 5020.1.doc
...Description of the Composition of the Drug Product..Description of the drug product.....Container Closure System..Description of the container-closure system used for the drug.....shows the location for product quality microbiology..information submitted in the CTD-Q..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=7)

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