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)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect on the.....A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a.....The valve should repeatedly dispense the aerosolized drug in discrete, accurate, small..
http://www.fda.gov/cder/fdama/difconc.htm (score=75)

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.....The physical characteristics, particularly the particle size of the drug substance, are very..
http://www.fda.gov/ora/inspect_ref/igs/oral.html (score=31)

Packaging
...The IND should describe the packaging and labeling used for the drug substance and the dosage.....Complete construction, composition, and description of all component parts of valve closure and container, including valve.....When drugs are administered by means of an aerosol dosage form, the valve closure system..
http://www.fda.gov/cder/guidance/package.htm (score=19)

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.....In one system this occurred, due to malfunction of the feedwater valve and level control..
http://www.fda.gov/ora/inspect_ref/igs/high.html (score=18)

GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS
...Associated with this problem is a change in the physical form of the drug substance and/or a.....When this valve is closed the chamber is isolated from the external condenser. Also known.....The Guide to Inspection of Computerized Systems in Drug Processing contains a discussion..
http://www.fda.gov/ora/inspect_ref/igs/lyophi.html (score=15)

Jurisdictional Update: Metered Dose Inhalers, Spacers and Other Accessories
...MDIs consist of a pressurized canister containing a drug substance and possibly excipients.....valve utilized in the product. For dose counters to provide accurate information, the.....Spacers will alter drug delivery characteristics to some extent, but do not specifically..
http://www.fda.gov/oc/combination/mdiupdate.html (score=13)

/a//content.15891
...healthy volunteers, any CNS active drug has the potential to impair judgment,thinking or.....substance? Yes, MERIDIA is a controlled substance in Schedule IV of the Controlled.....ultrasound testing to carefully look at heart valve structure and function. In one study..
http://www.fda.gov/cder/foi/label/2001/20632s8s11LBL.pdf (score=10)

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