Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....In an aseptic process, the drug product, container, and closure are first subjected to.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=100)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....In an aseptic process, the drug product, container, and closure are first subjected to.....terminally sterilized drug product, on the other hand, undergoes a single sterilization process..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=96)

Sterile Drug Products Produced by Aseptic Processing
...In an aseptic process, the drug product, container, and closure are first subjected to sterilization.....The sterile drug product and its container-closures should be protected by equipment of.....Drug product containers and closures shall be clean and, where indicated by the nature of the..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=81)

Guidance for Industry
...ensuring that the drug product provided to the patient has the appropriate identity, strength.....oxygen container, installed it on the argon container, and connected the deadly product to.....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=77)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...Finally, a finished drug product odor test must be performed on each container undergoing.....Drug product containers and closures play a critical role in assuring that the drug product.....This would pertain to any container or closure used to deliver industrial products, any..
http://www.fda.gov/cder/dmpq/freshair.htm (score=60)

MDI and DPI Drug Products
...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.....Documentation in Drug Applications for Container and Closure Systems Used for the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=57)

Guidance on the Packaging of Test Batches
...table of packaging information describing the container/closure system,the total number of.....For liquids, the total amount of bulk product packaged should be,at a minimum, 10 percent.....validation studies are conducted prior to the marketing of a drug product to assure..that..
http://www.fda.gov/cder/mapp/5225-1.pdf (score=54)

stability guidance -draft
...If testing of the drug product in the immediate container or as marketed is needed, the samples.....Stability data should be developed for the drug product in each type of immediate container and.....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=51)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....made to verify that the correct label has been affixed to the container and the shield.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=50)

CGMP Regulations
...Such procedures shall also require appropriate retesting of any component, drug product container, or.....The reserve sample shall be stored in the same immediate container-closure system in which the drug product is marketed or in one.....A drug product may be reprocessed provided the subsequent drug product meets appropriate..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=48)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface.....Container assemblies should be prepared at the beginning of the day before other daily.....A batch of a PET drug product is a predefined quantity of the drug that has been produced to..
http://www.fda.gov/cder/guidance/4259dft.htm (score=48)

Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...Specifications and testing procedures for CMG drug product container/closure systems should include the.....63 requires that equipment used in the manufacture, processing, packing, or holding of a drug.....For instance, a previous container label may be left on when the container is refilled, and the label need not be replaced unless..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=45)

Microsoft Word - 5320.1.doc
...Description of the Composition of the Drug Product..Description of the drug product composition.....Container Closure System..Description of the container-closure system used for the drug.....References to the corresponding drug product..sections of the CTD-Q and a reference to the ICH..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=43)

/a//content.14388
...Mixing, granulating, milling, molding, of components, drug product containers, formulating.....Therefore, under the Federal Food, all established standards, specifications, Drug, and.....drug product container, or closure, the.. require examination of the component.. validation provisions..
http://www.fda.gov/cder/dmpq/fr5396.pdf (score=41)

Microsoft Word - 5020.1.doc
...Description of the Composition of the Drug Product..Description of the drug product composition.....Container Closure System..Description of the container-closure system used for the drug.....References to the corresponding drug product..sections of the CTD-Q and a reference to the ICH..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=41)

Questions and Answers on Current Good Manufacturing Practices, Good...
...For container/closures purporting to be sterile or depyrogenated, sampling should be under.....Generally, we believe that sampling in a typical drug manufacturing facility warehouse.....Testing and approval or rejection of components, drug product container, and closures..
http://www.fda.gov/cder/guidance/cGMPs/production.htm (score=41)

Guidanc for Industry: Container and Closure Integrity Testing in Lieu of...
...than sterility testing to confirm container and closure integrity as a part of stability.....product varies with time under the influence of a variety of environmental factors such as.....microbial barrier, and, hence, the sterility of a drug product throughout its shelf..life..
http://www.fda.gov/cber/gdlns/contain.pdf (score=38)

WAIS Document Retrieval
...Background Persistent problems with drug product mislabeling and subsequent recalls in the late.....FDA is proposing to limit the scope of the cut labeling provision to immediate container.....container in which a drug product is commonly marketed at retail and many consumers read this labeling when..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=36)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...Miscellaneous drug product impurities include, for example, container closure system leachables.....If drug substance and drug product information is provided in an appendix, the preferred presentation is drug.....7 and the container closure system used for storage and transportation of protein drug..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=36)

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.....If they do, adequate information to justify the use of the container system in combination with the drug product should be..
http://www.fda.gov/cder/guidance/package.htm (score=35)

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