This page contains a list of all PQRI Working Groups. Detailed work plans and minutes from Working Group meetings are also highlighted.

Each Working Group is overseen by one of PQRI’s four Technical Committees. For more information about these Technical Committees, please click here.

DPTC Working Groups Radio Frequency Identification (RFID) Container/Closure Systems Excipients Particle Size Distribution Mass Balance Particle Size Distribution Profile Comparisons Leachables and Extractables Blend Uniformity Working Group Stability Shelf Life Working Group Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group

DSTC Working Groups Impurities Physical Attributes/Particle Size Specifications/BACPAC

MTC Working Groups Process Robustness Post Approval Changes for Sterile Products Case Studies for Risk Management Biologicals Inspection Survey Aseptic Processing

BTC Working Groups Sequential Design Dissolution BCS Class III Immediate Release Oral Drug Products

Radio Frequency Identification Working Group (RFID WG)
(Chairs) Robert Seevers and Toby Massa

The RFID WG is looking at implications of using radio-frequency identification devices on boxes containing pharmaceutical products.

Future FDA RFID Guidance

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Container/Closure Systems
(Chairs) Daniel Malinowski

The Container/Closure Systems WG is developing test methods and evaluation criteria in support of FDA's PACPAC guidance.

Draft Guidance for Industry Stability Testing of Drug Substances and Drug Products (Draft June 1998) http://www.fda.gov/cder/guidance/1707dft.pdf

Final Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999) http://www.fda.gov/cder/guidance/1714fnl.pdf

Final Guidance for Industry Changes to an Approved NDA and ANDA (November 1999) http://www.fda.gov/cder/guidance/2766fnl.pdf

Meeting Minutes

• September 27, 2006 (PDF)
• June 14, 2005 (PDF)
• May 13, 2005 (PDF)
• January 27, 2004 (PDF)
• December 6, 2001 (PDF)

Additional Material of the Container/Closure Systems Working Group

• Protocol for HDPE Container MVTR Measurement (DOC)

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Excipients
(Chair) Robert Wiens

The Excipients WG is developing current practices for control of excipients and will explore ways for more efficient controls.

Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information (2003) http://www.fda.gov/cder/guidance/1215dft.pdf

“PQRI Survey of Pharmaceutical Excipient Testing and Control Strategies Used by Excipient Manufacturers, Excipient Distributors, and Drug-Product Manufacturers”, Pharmaceutical Technology Sep 2, 2006, pg. 90, Gregory Larner, David R. Schoneker, Catherine Sheehan, Rajendra Uppoor, Phyllis Walsh, Robert Wiens.

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)

Work Plan

• Excipient Control Strategy Work Plan (PDF)
• Survey Timeline
  
  

Meeting Minutes

• April 7, 2005 (PDF)
• March 24, 2005 (PDF)
• March 17, 2005 (PDF)
• March 3, 2005 (PDF)
• January 27, 2005 (PDF)
• January 13, 2005 (PDF)

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Particle Size Distribution: Mass Balance Working Group
(Chairs) Bruce Wyka and Terry Tougas

The Aerodynamic Particle Size Distribution Mass Balance WG is evaluating the suitability of specifications for mass balance obtained from cascade impactor measurements, as recommended in draft FDA guidances for orally inhaled and intranasal drug products.

Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documents (1998). http://www.fda.gov/cder/guidance/2180dft.pdf

Final Guidance for Industry-Nasal Spray Drug Products Chemistry, Manufacturing, and Control Documentation (2002) http://www.fda.gov/cder/guidance/4234fnl.pdf

Work Plan

Establishment of the Appropriate Use of the Particle Size Distribution Mass Balance Determined by Cascade Impactor for Orally Inhaled and Nasal Drug Products (PDF)

Meeting Minutes

• February 22, 2006 (PDF)
• October 11, 2005 (PDF)
• September 22, 2005 (PDF)
• August 17, 2005 (PDF)
• June 10, 2005 (PDF)
• April 29, 2005 (PDF)
• October 13, 2004 (PDF)
• September 20, 2004 (PDF)
• September 20, 2004 (PDF)
• August 17, 2004 (PDF)
• July 20, 2004 (PDF)
• June 28, 2004 (PDF)
• June 4, 2004 (PDF)
• June 1, 2004 (PDF)
• March 19, 2004 (PDF)
• February 23, 2004 (PDF)
• August 5, 2003 (PDF)
• July 23, 2003 (PDF)
• July 2, 2003 (PDF)
• June 4, 2003 (PDF)
• May 14, 2003 (PDF)
• April 3, 2003 (PDF)
• March 3, 2003 (PDF)
• January 24, 2003 (PDF)
• December 19, 2002 (PDF)
• November 8, 2002 (PDF)
• October 21, 2002 (PDF)
• September 24-25, 2002 (PDF)
• July 29, 2002 (PDF)
• July 3, 2002 (PDF)
• May 30, 2002 (PDF)
• May 13, 2002 (PDF)
• March 25, 2002 (PDF)
• February 25, 2002 (PDF)
• February 14, 2002 (PDF)
• January 29, 2002 (PDF)
• December 18, 2001 (PDF)
• November 30, 2001 (PDF)
• November 19, 2001 (PDF)

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Particle Size Distribution: Profile Comparisons Working Group
(Chair) David Christopher

The Aerodynamic Particle Size Distribution Profile Comparisons WG is developing a robust statistical method (and evaluating that proposed in a draft FDA guidance) for establishing in vitro bioequivalence of aerosol particle size distributions of orally inhaled and intranasal drug products.

Draft Guidance for Industry-Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (1999, second draft 2003) http://www.fda.gov/cder/guidance/5383DFT.doc

Work Plan

Investigation of an Optimized Chi-square Method for Comparing Particle Size Distribution Profiles Obtained by Cascade Impactors with Specific Reference to Equivalence Testing of Orally Inhaled and Pressurized Nasal Drug Products (PDF)

Meeting Minutes

• January 12, 2007 (PDF)
• December 11, 2006 (PDF)
• September 18, 2006 (PDF)
• August 28, 2006 (PDF)
• July 31, 2006 (PDF)
• July 10, 2006 (PDF)
• June 15, 2006 (PDF)
• May 22, 2006 (PDF)
• April 12, 2006 (PDF)
• March 7, 2006 (PDF)
• January 9, 2006 (PDF)
• December 14, 2005 (PDF)
• December 1, 2005 (PDF)
• November 16, 2005 (PDF)
• October 19, 2005 (PDF)
• October 3, 2005 (PDF)
• July 13, 2005 (PDF)
• May 25, 2005 (PDF)
• May 11, 2005 (PDF)
• April 13, 2005 (PDF)
• March 23, 2005 (PDF)
• March 2, 2005 (PDF)
• February 16, 2005 (PDF)
• January 12, 2005 (PDF)
• December 15, 2004 (PDF)
• October 27, 2004 (PDF)
• September 22, 2004 (PDF)
• July 7, 2004 (PDF)
• June 23, 2004 (PDF)
• June 6, 2004 (PDF)
• May 26, 2004 (PDF)
• May 13, 2004 (PDF)
• April 27, 2004 (PDF)
• March 30, 2004 (PDF)
• March 15, 2004 (PDF)
• March 9, 2004 (PDF)
• March 3, 2004 (PDF)
• February 2, 2004 (PDF)
• January 13, 2004 (PDF)
• December 19, 2003 (PDF)
• August 5, 2003 (PDF)
• July 29, 2003 (PDF)
• June 26, 2003 (PDF)
• May 5, 2003 (PDF)
• April 2, 2003 (PDF)
• October 30, 2002 (PDF)
• October 24, 2002 (PDF)
• October 7, 2002 (PDF)
• September 16, 2002 (PDF)
• September 12, 2002 (PDF)
• August 30, 2002 (PDF)
• August 9, 2002 (PDF)
• July 18, 2002 (PDF)
• June 27, 2002 (PDF)
• June 4, 2002 (PDF)
• May 14, 2002 (PDF)
• April 17, 2002 (PDF)
• March 15, 2002 (PDF)
• January 28, 2002 (PDF)
• January 22, 2002 (PDF)
• December 6, 2001 (PDF)
• November 26, 2001 (PDF)
• November 16, 2001 (PDF)

Additional Materials of the Profile Comparison Working Group

• PBE Test Description (PDF)
• Systematic Study of 38 Scenarios (PDF)
• Realistic Scenarios 1-33 of 55 (PDF)
• Realistic Scenarios 34-55 of 55 (PDF)
• Statistical Comparison of Particle Size Distribution Profiles (DOC)
• Searching for the Holy Grail of a Single PSD Profile Comparator (PPT)
• Draft Simulation Results on Stability of the Chi-Square Ratio Statistic Under the Null Case of Identical Sets of Reference and Test Profiles (PPT)
• PQRI APSD Profile Comparisons Working Group's Assessment (XLS)
• Thumbnail Plots and Scenario Descriptions (PDF)

PSD Profile Summary Discussion Comparison Subgroup

• March 9, 2004
• February 10-25, 2004

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Leachables and Extractables
(Chair) Daniel Norwood

The Leachables and Extractables WG is developing reporting and qualification thresholds for leachables in orally inhaled and intranasal drug products.

Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documents (1998). http://www.fda.gov/cder/guidance/2180dft.pdf

Final Guidance for Industry-Nasal Spray Drug Products Chemistry, Manufacturing, and Control Documentation (2002) http://www.fda.gov/cder/guidance/4234fnl.pdf

Work Plan

Development of Scientifically Justifiable Thresholds for Leachables and Extractables (PDF)

Meeting Minutes

• January 14, 2005 (PDF)
• December 17, 2004 (PDF)
• December 1, 2004 (PDF)
• October 7, 2004 (PDF)
• October 5, 2004 (PDF)
• October 1, 2004 (PDF)
• September 28, 2004 (PDF)
• August 9, 2004 (PDF)
• July 13, 2004 (PDF)
• July 9, 2004 (PDF)
• May 17, 2004 (PDF)
• April 20, 2004 (PDF)
• April 16, 2004 (PDF)
• April 1, 2004 (PDF)
• March 24, 2004 (PDF)
• March 16, 2004 (PDF)
• February 2, 2004 (PDF)
• January 23, 2004 (PDF)
• November 19, 2003 (PDF)
• November 10, 2003 (PDF)
• September 23, 2003 (PDF)
• September 10, 2003 (PDF)
• August 19, 2003 (PDF)
• August 4, 2003 (PDF)
• July 2, 2003 (PDF)
• April 30, 2003 (PDF)
• April 16, 2003 (PDF)
• April 9, 2003 (PDF)
• April 7, 2003 (PDF)
• April 3, 2003 (PDF)
• March 7, 2003 (PDF)
• February 28, 2003 (PDF)
• February 26, 2003 (PDF)
• February 21, 2003 (PDF)
• January 29, 2003 (PDF)
• January 28, 2003 (PDF)
• January 23, 2003 (PDF)
• January 9, 2003 (PDF)
• December 11, 2003 (PDF)
• December 17, 2002 (PDF)
• December 4, 2002 (PDF)
• November 12, 2002 (PDF)
• October 24, 2002 (PDF)
• September 20, 2002 (PDF)
• July 26, 2002 (PDF)
• July 3, 2002 (PDF)
• July 2, 2002 (PDF)
• June 20, 2002 (PDF)
• May 31, 2002 (PDF)
• May 8, 2002 (PDF)
• April 22, 2002 (PDF)
• April 9, 2002 (PDF)
• February 14, 2002 (PDF)
• January 22, 2002 (PDF)
• December 17, 2001 (PDF)
• November 30, 2001 (PDF)
• November 16, 2001 (PDF)

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Blend Uniformity Working Group

Meeting Minutes

• January 29, 2002 (PDF)
• January 25, 2001

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Stability Shelf Life Working Group

Meeting Minutes

• May 9-10, 2007 (PDF)
• December 18, 2006 (PDF)
• December 12, 2006 (PDF)
• November 30, 2006 (PDF)

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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

Membership Criteria (PDF)
Proposal (PDF)

Meeting Minutes

• April 23, 2008 (PDF)
• January 8, 2008 (PDF)
• December 20, 2007 (PDF)
• July 9, 2007 (PDF)

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Impurities
(Chair) Chun Chow Chan

The Impurities WG is determining appropriate methods and extent of characterization for impurities as a function of the stage of product development.

ICH Q3A http://www.fda.gov/cder/guidance/Q3Cfnl.pdf

Impurities Working Group Survey

• PQRI API Impurities Working Group Questionnaire Cover Letter (PDF)
• Impurity Characterization and Quantification Questionnaire (PDF)

Meetings Minutes

Physical Attributes/Particle Size Working Group
(Chair) Sharon Snorek

The Physical Attributes/ Particle Size WG is discussing test methods and specification-setting for particles of active pharmaceutical ingredients in oral dosage forms.

ICH Q2A http://www.fda.gov/cder/guidance/ichq2a.pdf
ICH Q2B http://www.fda.gov/cder/guidance/1320fnl.pdf
ICH Q6A http://www.fda.gov/OHRMS/DOCKETS/98fr/122900d.pdf

Work Plan

Drug Substance Particle Size Work Plan (PDF)

Meeting Minutes

• March 26, 2001 (PDF)
• April 27, 2001 (PDF)
• March 20, 2001

Specifications/BACPAC Working Group
(Chair) Angelos Dovletoglou

The Specifications/ BACPAC WG is considering a core set of specifications (test, analytical methods, and acceptance criteria) that would assure the identity, strength, quality, purity and potency of a drug substance following a manufacturing change after the final intermediate.

Guidance for Industry BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation http://www.fda.gov/cder/guidance/3629fnl.htm

Meeting Minutes

• June 24, 2002 (PDF)
• March 20, 2002 (PDF)
• February 20, 2002 (PDF)
• January 29, 2002 (PDF)
• October 16, 2001 (PDF)
• August 15, 2001 (PDF)
• July 18, 2001 (PDF)
• March 20, 2001 (PDF)

Process Robustness Working Group

The Process Robustness WG is developing an industry-wide understanding of factors that influence complexity and robustness of processes for oral solid dosage forms.

Work Plan

Process Robustness Work Plan (PDF)

Post Approval Changes for Sterile Products Working Group

Post Approval Changes for Sterile Products WG will work to develop a listing of common changes which occur in the manufacturing of sterile products and will provide recommendations on the risk associated with these changes.

Post Approval Changes for Sterile Products Working Group (PDF)

Case Studies for Risk Management Working Group

The Case Studies for Risk Management WG will develop specific examples where different risk models have been used within the spectrum of pharmaceutical industry, spanning pharmaceutical development through manufacturing (“case studies”), and training in how to use these models.

Biologicals Inspection Survey Working Group

The Biologicals Inspection Survey WG will evaluate and assess Team Biologicals inspections by conducting a survey of industry.

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

Aseptic Processing Working Group

Work Plan

Aseptic Processing Work Plan (PDF)

Meeting Minutes

• February 27 & 28, 2003 (PDF)
• February 6, 2003 (PDF)
  • Power Point Presentation Attachment (PDF)
• January 23, 2003 (PDF)
• January 16, 2003 (PDF)
• January 9, 2003 (PDF)

Sequential Design Working Group

The Sequential Design WG is developing appropriate statistical methods to justify the approach of using sequential design methods to permit the pooling of pharmacokinetic data from multiple studies to justify a bioequivalance of a product.

Dissolution Working Group

Dissolution WG is considering a core set of dissolution methods that would be applied to all products to aid in the identification of a dissolution method that is predictive of in vivo behavior for a given compound.

BCS Class III Biowaiver Working Group

BCS Class III Biowaiver WG is collecting and analyzing data to determine the viability of biowaivers for BCS Class III compounds.

PQRI Survey Of Oral Ionizable Drugs (PDF)
PQRI Survey OF Oral Ionizable Drugs (MS Word)

Immediate Release Oral Drug Products Working Group

Meeting Minutes

• July 10, 2002 (PDF)
• November 30, 2001 (PDF)M