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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

Recommendations

L/E Recommendations to the FDA - Cover Letter (PDF)
L/E Recommendations to the FDA (PDF, 2MB)

Container/Closure Systems

(Chair) Daniel Malinowski

“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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