MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....stem orifice of the valve, the vapor pressure in the container, and the nature of the.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Packaging
...The IND should describe the packaging and labeling used for the drug substance and the dosage.....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..
http://www.fda.gov/cder/guidance/package.htm (score=65)

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.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can.....A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a..
http://www.fda.gov/cder/fdama/difconc.htm (score=45)

GUIDE TO INSPECTIONS OF
...In the bulk drug substance industry, particularly for parenteral grade substances, it is common.....If on the next day or start-up of the operation the primary valve off of the circulating.....One of the basic considerations in the design of a system is the type of product that is..
http://www.fda.gov/ora/inspect_ref/igs/high.html (score=40)

GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS , FDA, ORA
...Observe the addition of drug substance and powdered excipients to manufacturing vessels to.....The design of the batching tank with regard to the location of the bottom discharge valve.....From a potency aspect, the storage of product at high temperatures may increase the level..
http://www.fda.gov/ora/inspect_ref/igs/oral.html (score=31)

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