What is PQRI? Learn more here! (PDF)

BioThree Work Group

The Influence of Chitosan on the Oral Bioavailability of Acyclovir—a Comparative Bioavailability Study in Humans

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FDA/PQRI Conference on Evolving Product Quality

Implementation Challenges for ICH’s New M7 Guideline

ICH Q3D Process Opens the Door to Broader Participation; USP Announces Possibly Delaying Heavy Metal Chapter Deadlines

New CMC Submission Approach Needed to Foster Transparency and Continuous Improvement, PhRMA Team Says; Embedding Control Strategy as Regulatory Commitment in QOS Proposed

Steering Committee

Bringing a Science-Based Approach to Regulation: The Story of the Product Quality Research Institute

Best Practices for the Development, Scale-up and Post Approval Change of IR & MR Dosage Forms in the Current Quality by Design Paradigm

Development Technical Committee (DTC)

Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products – Workshop Summary Report

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

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

(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.

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

Hancock BC, Garcia-Munoz S, “How do formulation and process parameters impact blend and unit dose uniformity?” (PDF), submitted to the Journal of Pharmaceutical Sciences.

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

Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products by Daniel L. Norwood, Lee M. Nagao, and Cherry L.M. Stults

Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

• A Review, by John A. Budny, PharmaCal, Ltd.

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.

Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group

Diane Paskiet, Chair
Doug Ball, Toxicology Co-chair
Dennis Jenke, Chemistry Co-chair

The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Opthalmic Drug Product (PODP) by Diane Paskiet, Dennis Jenke, Douglas Ball, et al.

Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products

Simulated Leaching (Migration) Study for a Model Container Closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs)

Stability Shelf Life Work Group

On the Shelf Life of Pharmaceutical Products

 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
• Determination of Water Vapor Transmission Rate for Various High Barrier Blister Packs
• Determination of Water Vapor Transmission Rate for High Density Polyethylene Screw-cap Bottles

Excipients

(Chair) Robert Wiens

• 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

(Chairs) Robert Seevers and Toby Massa

Cover Story in PQRI Newsletter Feb 2005 (PDF)

Recommendations

RFID Report to the FDA – March 23, 2006 (PDF)

Specifications

(Chair) Angelos Dovletoglou

Impurities

(Chair) Chun Chow Chan

Physical Attributes/Particle Size of API

Sulfonate Esters

1. K.Jacq, E.Delaney, A.Teasdale, et al, Development and validation of an automated static headspace gas chromotography-mass spectrometry (SHS-GC-MS) method for monitoring the formation of ethyl methane sulfonate from ethanol and methane sulfonic acid, J.Pharm. Biomed. Anal, 2008, 48(5), 1339.
2. D Elder, E Delaney, A Teasdale et al, The Utility of Sulfonate Salts in Drug Development. Journal of pharmaceutical sciences, 2010, 99, 2948-2961. – Related Paper
3. A Teasdale, E J. Delaney, S C. Eyley et al, A Detailed Study of Sulfonate Ester Formation and Solvolysis Reaction Rates and Application toward Establishing Sulfonate Ester Control in Pharmaceutical Manufacturing Processes. Organic Process Research & Development 2010,14, 999–1007
4. Teasdale, et al. 2012. An Approach to Control Strategies for Sulfonate Ester Formation in Pharmaceutical Manufacturing Based on Recent Scientific Understanding. Org. Process Res. Dev. 16 (11), 1707–1710.

“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.

Biopharmaceutics Technical Committee (BTC)

The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers. Parr, Alan; Hidalgo, Ismael J.; Bode, Chris; Brown, William; Yazdanian, Mehran; Gonzalez, Mario A.; Sagawa, Kazuko; Miller, Kevin; Jiang, Wenlei; Stippler, Erika S., August 2015, Pharmaceutical Research.

Sequential Design Work Group

Sequential design approaches for bioequivalence studies with crossover designs (PDF)

Manufacturing Technical Committee (MTC)

PQRI Comments to Docket FDA-2014-D-0779

Ref: Docket FDA-2014-D-0779, “Draft Guidance for Industry on Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act; Availability”

Specifications Design and Life Cycle Work Group

Quality by Design Specifications for Solid Oral Dosage Forms: Multivariate Product and Process Monitoring for Managing Drug Quality Attributes

Process Drift Workshop

FDA Perspectives: Detection, Measurement, and Control in Manufacturing

Risk Management Work Group

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

Case Studies:

• 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)
  • Pharmtech.com PQRI Case Study: Functional Equivalence for Equipment Replacements
• 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)
  • Pharmtech.com PQRI Case Study: Defining Process Design Space
• Case Study RMWG-08 Empty Capsules (PDF)
  • Pharmtech.com PQRI Case Study: Process Deviation and Empty Product Capsules

Training Guides:

• FMEA Training Guide (PDF)
• HACCP Training Guide (PDF)
• HAZOP Training Guide (PDF)
• Risk Rank Filter Training Guide (PDF)

Process Robustness Work Group

Process Robustness – A PQRI White Paper (PDF)

Team Biologics Work Group

Results of a Survey of Biological Drug and Device Industries Inspected by FDA under the Team Biologics Program (PDF)

Transdermals

Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles
Glenn A. Van Buskirk, Daniel Arsulowicz2 Prabir Basu, Lawrence Block, Bing Cai, Gary W. Cleary, Tapash Ghosh, Mario A. González, David Kanios, Margareth Marques, Patrick K. Noonan, Terrance Ocheltree, Peter Schwarz, Vinod Shah, Thomas S. Spencer, Lino Tavares, Katherine Ulman, Rajendra Uppoor, and Thean Yeoh;
AAPS PharmSciTech (# 2011)
DOI: 10.1208/s12249-011-9740-9

The Post Approval Changes for Sterile Products WG

Post Approval Changes for Sterile Products Working Group (PDF)

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