DPTC
Blend Uniformity
(Chair)Tom Garcia
Boehm, et.al., "Results of Statistical Analysis of Blend and Dosage Unit Content Uniformity Data Obtained from the Product Quality Research Institute Blend Uniformity Working Group Data-Mining Effort," PDA Journal of Pharmaceutical Science and Technology, March/April 2004, p.62.
Boehm, et.al., "The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends," PDA Journal of Pharmaceutical Science and Technology, Vol. 57, No. 2, March/April 2003, p. 64.
“Report on the Industry Blend Uniformity Practices Survey”, Pharmaceutical Technology, August 2001, p. 20.
Particle Size Distribution: Mass Balance
(Chairs) Bruce Wyka and Terry Tougas
Christopher, D., Curry, P., Doub, B., Furnkranz, K., Lavery, M., Lin, K., Lyapustina, S., Mitchell, J., Rogers, B., Strickland, H., Tougas, T., Tsong, Y., and Wyka, B. 2003. Considerations for the Development and Practice of Cascade Impaction Testing, Including a Mass Balance Failure Investigation Tree. J. Aerosol Med. 16 (3):235-247.
Mitchell, J. P. 2003. Regarding the Development and Practice of Cascade Impaction Testing, Including a Mass Balance Failure Investigation,” J Aerosol Med. 16 (4):433.
Particle Size Distribution: Profile Comparisons
(Chair) David Christopher
Manuscript in preparation, under PQRI review:
“Evaluation Of A Method For Determining Equivalence Of Cascade Impaction Profiles Of Pharmaceutical Aerosols: PQRI Working Group’s Progress Report” by Wallace, P. A., Christopher, D., Lee, D.S., Morgan, B., Pan, Z., Singh, G.J.P., Tsong, Y., and Lyapustina, S.
Leachables and Extractables
(Chair) Daniel Norwood
“Basis for Using Moisture Vapor Transmission Rate per Unit Product in the Evaluation of Moisture-Barrier Equivalence of Primary Packages for Solid Oral Dosage Forms” by PQRI Container–Closure Working Group (J. Barry; J. Bergum; Y. Chen; R. Chern; R. Hollander; D. Klein; H. Lockhart. D. Malinowski; R. McManus; C. Moreton; A. Mueller; L. Nottingham; C. Okeke; D. O'Reilly; K. Rinesmith; S. Shorts). Pharmacopeial Forum vol 31(1) 2005
Excipients
(Chair) Robert Wiens
RFID
(Chairs) Robert Seevers and Toby Massa
Cover Story in PQRI Newsletter Feb 2005 (PDF)
Recommendations
RFID Report to the FDA - March 23, 2006 (PDF)
DSTC
Specifications
(Chair) Angelos Dovletoglou
Impurities
(Chair) Chun Chow Chan
Physical Attributes/Particle Size of API
BTC
Coming Soon
MTC
Process Robustness – A PQRI White Paper (PDF)
Results of a Survey of Biological Drug and Device Industries Inspected by FDA under the Team Biologics Program (PDF)
Post Approval Changes for Sterile Products Working Group (PDF)
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