Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...The manifolds are equipped with fill connections that correspond only to the container valve.....Specifications and testing procedures for CMG drug product container/closure systems.....A visual external inspection of each valve and container for dents, arc burns, other..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=100)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....stem orifice of the valve, the vapor pressure in the container, and the nature of the.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=15)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....Complete construction, composition, and description of all component parts of valve closure and container, including valve.....If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier..
http://www.fda.gov/cder/guidance/package.htm (score=15)

Guidance for Industry
...valve assembly, the acceptability of the valve packing and the valve seal used, the type.....container and attached it to the container containing argon, and was able to fill the.....adverse drug experience, which is required to be reported to the Food and Drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=15)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The aerosol dispenser consists primarily of a metal or glass container, a valve assembly, and an.....The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....In MDI products, the container closure system consists of the container, the valve and its components, the actuator, additional..
http://www.fda.gov/cder/fdama/difconc.htm (score=14)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...problems associated with the valve, the valve seal material, ejection of valve stems, the container whether.....This would include any problems associated with the drug product, the valve, the high.....Finally, a finished drug product odor test must be performed on each container undergoing..
http://www.fda.gov/cder/dmpq/freshair.htm (score=14)

Human Drug Notes
...The CGMP regulations promulgated under the Food, Drug, and Cosmetic Act 5 HUMAN DRUG CGMP NOTES June, 1995 and codified.....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=13)

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