MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....stability test storage conditions. Additional studies should be performed to characterize.....stem orifice of the valve, the vapor pressure in the container, and the nature of the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...This would include any problems associated with the drug product, the valve, the high pressure cylinder, etc.....The valve packing leak test is required to be performed with the cylinder under pressure and while the.....Finally, a finished drug product odor test must be performed on each container undergoing..
http://www.fda.gov/cder/dmpq/freshair.htm (score=85)

Packaging
...It should provide an adequate seal, be compatible with the drug product, and not be a source of.....Complete construction, composition, and description of all component parts of valve closure and container, including valve.....A further test to supplement the mouse subchronic systemic test is the procedure for eye..
http://www.fda.gov/cder/guidance/package.htm (score=68)

Guidance for Industry
...ensuring that the drug product provided to the patient has the appropriate identity, strength.....The Agency recommends that a valve assembly leak test be performed during the cylinder.....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=67)

Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...63 requires that equipment used in the manufacture, processing, packing, or holding of a drug.....In the latter instance, testing the first container filled serves both as a component test and as a finished product test.....The manifolds are equipped with fill connections that correspond only to the container..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=64)

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