MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....program because they can affect the ability of the product to deliver reproducible doses.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....used if such approach satisfies the requirements of the applicable statutes and.....made to verify that the correct label has been affixed to the container and the shield..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=97)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Currently, a batch, or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug product in a.....A string label can be used by PET centers to label the immediate container provided that there is a way to associate the label with.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface..
http://www.fda.gov/cder/guidance/4259dft.htm (score=93)

Document
...number in this manner would, code requirement, and we consider drug doses of the drug.....drugs are used in hospitals, so bar codes errors involving radiopharmaceuticals, bar codes.....manufacturer, product, and package. prevent the introduction, transmission, drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=90)

...To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....Because the product is marketed and the dose that is thought to be appropriate and well tolerated is known, there.....A description of the container/closure in which the botanical drug substance is to be..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=78)

stability guidance -draft
...If testing of the drug product in the immediate container or as marketed is needed, the samples.....demonstrate that the closure used with a multiple-dose vial is capable of withstanding the.....Stability data should be developed for the drug product in each type of immediate container and..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=76)

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