Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...Specifications and testing procedures for CMG drug product container/closure systems should include the.....The manifolds are equipped with fill connections that correspond only to the container valve.....63 requires that equipment used in the manufacture, processing, packing, or holding of a drug..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=100)

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.....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=39)

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.....problems associated with the valve, the valve seal material, ejection of valve stems, the container whether.....Finally, a finished drug product odor test must be performed on each container undergoing..
http://www.fda.gov/cder/dmpq/freshair.htm (score=34)

...Release of the drug from the drug product produces droplet or drug particle sizes and distribution patterns.....Container and Closure System Nasal aerosols usually consist of the formulation, container, valve.....From a product quality perspective, the critical issues are release of drug substance from drug product and..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=34)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...information that pertains to the identity, strength,quality, purity, and potency of a drug.....Nasal aerosols consist of the formulation, container, valve, actuator, dust cap.....affect the BA of the drug product as a result of different solubilities and/or rates of..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=34)

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.....valve assembly, the acceptability of the valve packing and the valve seal used, the type..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=34)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....Complete construction, composition, and description of all component parts of valve closure and container, including valve.....It is also possible for a component of the drug product to migrate through the walls of the..
http://www.fda.gov/cder/guidance/package.htm (score=27)

Human Drug Notes
...Any residues must not adversely alter drug product safety, efficacy, quality, or stability.....valve and external examination, labeling, coloring, correct valve, etc. Finally, the firm.....122(g) for items of labeling other than immediate container labels is being extended to..
http://www.fda.gov/cder/hdn/hdn695.htm (score=21)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....Each time a pharmacist removes a sterile product from its original container or reconstitutes a sterile product, a.....The aerosol dispenser consists primarily of a metal or glass container, a valve assembly, and an..
http://www.fda.gov/cder/fdama/difconc.htm (score=18)

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