MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236.....drug substance, optimized formulation, valve and actuator design, 89.. manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The acceptance criteria should at a minimum meet the criteria proposed in The Pharmacopeial Forum.63.....The aerosol dispenser consists primarily of a metal or glass container, a valve assembly.....At a minimum, the acceptance criteria should meet the criteriaproposed in the Pharmacopeial Forum.58..
http://www.fda.gov/cder/fdama/difconc.htm (score=27)

GUIDE TO INSPECTIONS OF
...Another major consideration in the validation of high purity water systems is the acceptance criteria.....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=22)

Guidance for Industry
...valve assembly, the acceptability of the valve packing and the valve seal used, the type.....Each medical gas container and closure, upon receipt and before acceptance, must be.....would examine whether any of the threads on the valve or on top of the valve stem are..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=21)

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.....acceptance criteria, and the course of action to be taken if test results fall outside of.....At this time, each cylinder valve assembly is tested for valve packing leaks, safety plug leaks and other valve leaks..
http://www.fda.gov/cder/dmpq/freshair.htm (score=21)

Saline, Silicone Gel, and Alternative Breast Implants - Draft Guidance for...
...Valve competence tests are performed to demonstrate that valve integrity is maintained at.....silicone gel-filled, saline-filled, or alternative), as well as the criteria and method.....acceptance criteria for components or processes that contribute to device failure..
http://www.fda.gov/cdrh/ode/guidance/1239.html (score=21)

ENFORCEMENT REPORT FOR 02/03/1999
...Blood product was collected from a donor who exceeded the donation acceptance criteria for body.....The testing firm inappropriately released the heart valve based on negative confirmatory.....Human Aortic Heart Valve for Transplantation, Model No. AV00. Recall #Z-479-9. CODE..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00575.html (score=21)

PMA Final Decisions Rendered for November 2003
...Discontinue the use of Reference Panel 4 and eliminate all associated validity and acceptance.....valve, sizes 19, 21, 23, 25, 27, and 29 mm. The device, as modified, will be marketed.....criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart..
http://www.fda.gov/cdrh/pma/pmanov03.html (score=21)

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