DTC

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs)

Workshop Summary Report
(from the Journal of Aerosol Medicine and Pulmonary Drug Delivery)

Blend Uniformity

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.

The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends (PDF)

Particle Size Distribution: Mass Balance

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

Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations

Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug Product Evaluation (PDF)
Douglas Ball, James Blanchard, David Jacobson-Kram, Roger O. McClellan, Timothy McGovern, Daniel L. Norwood, Mark Vogel, Ron Wolff, Lee Nagaott. Submitted to Toxicological Sciences for consideration as a Review article.

Recommendations

Container/Closure Systems

"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

• PQRI Survey Findings of Pharmaceutical Excipient Testing and Control Strategies, Used By Excipient Manufacturers, Excipient Distributors and Drug Product Manufacturers (PDF)
• Joint Position Paper From Excipient Manufacturers, Drug Product Manufacturers and USP on Pharmaceutical Excipient Testing and Control Strategies; Based on a PQRI Survey and Workshop (PDF)

RFID

Cover Story in PQRI Newsletter Feb 2005 (PDF)

Recommendations

Specifications

Impurities

Physical Attributes/Particle Size of API

Sulfonate Esters

“Mechanism and Processing Parameters Affecting the Formation of Methyl Methanesulfonate from Methanol and Methanesulfonic Acid: An Illustrative Example for Sulfonate Ester Impurity Formation” by Andrew Teasdale, Stephen C. Eyley, Ed Delaney, Karine Jacq, Karen Taylor-Worth, Andrew Lipczynski, Van Reif, David P. Elder, Kevin L. Facchine, Simon Golec, Rolf Schulte Oestrich, Pat Sandra, and Frank David. Org. Process Res. Dev. January 22, 2009.

BTC

MTC

Quality Risk Management Principles and Industry Case Studies - December 28, 2008 (PDF)

• Case Study RMWG-01 Internal GMP Audit Program (PDF)
• Case Study RMWG-02 - Non-Sterile Facility Cleaning (rev 1) (PDF)
• Case Study RMWG-03 - Functional Equivalence for Equipment Replacements (rev 1) (PDF)
• Case Study RMWG-04 draft 05 Feb 08 (PDF)
• Case Study RMWG-05 - Packaging Line Optimization (PDF)
• PQRI Case Study RMWG-06 Packout (PDF)
• Case Study RMWG-07 Defining Process Space (PDF)
• Case Study RMWG-08 Empty Capsules (PDF)

FMEA Training Guide (PDF)

HACCP Training Guide (PDF)

HAZOP Training Guide (PDF)

Risk Rank Filter Training Guide (PDF)

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)

The Post Approval Changes for Sterile Products WG

Post Approval Changes for Sterile Products Working Group (PDF)

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