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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.

DTC 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
Biological Inspections Working Group
Stability Shelf Life Working Group
Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group
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
Nanotechnology
Sequential Design
Dissolution
BCS Class III
Immediate Release Oral Drug Products

DTC Working Groups

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

Container Closure Working Group Update Intro

Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

PQRI Update -June 2011 (Power Point Presentation)

New ASTM Standards—Labels in Anesthesiology and Pharmaceutical Packaging

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Draft Guidance for Industry Stability Testing of Drug Substances and Drug Products (Draft June 1998) http://www.fda.gov/cder/guidance/1707dft.pdf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

Additional Material of the Container/Closure Systems Working Group

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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.

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

PQRI Survey Findings of Pharmaceutical Excipient Testing and Control Strategies, Used By Excipient Manufacturers, Excipient Distributors and Drug Product Manufacturers

Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information (2003) http://www.fda.gov/cder/guidance/1215dft.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

Work Plan

Meeting Minutes

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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

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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

Additional Materials of the Profile Comparison Working Group

PSD Profile Summary Discussion Comparison Subgroup

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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.

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

"Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations", Pharm Research, 25(4), 727-739 (2008) is available in full on the Open Access link at http://www.springerlink.com/content/m4352271h4856p67/?p=eb4f04ace7e84033a1807a710c7bc01a&pi=1

Work Plan

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

Meeting Minutes

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Blend Uniformity Working Group

Meeting Minutes

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Biological Inspections Working Group

PQRI Biologics Survey (PDF)

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Stability Shelf Life Working Group

SSLWG Glossary Version 1.0 (PDF)
PQRI SSL WG Webinar Presentation - 08 July 2008 (PDF)
Direct Approaches to Shelf Life Estimation (Presentation Slides) (PDF)
Direct Approaches to Shelf Life Estimation (Poster) (PDF)
Evaluating Tolerance Interval Estimates: To Capture or Not to Capture (Presentation Slides) (PDF)
Proposed Methodology for Shelf Life Estimation (Presentation Slides) (PDF)
Estimating Shelf Life Using Quantile Regression with Random Batch Effects (Presentation Slides) (PDF)
PQRI Stability Shelf Life Working Group (PDF)
Establishing the Shelf Life of Pharmaceutical Products (PDF)
Comparing Statistical Interval Estimates (Presentation Slides) (PDF)
Evaluating Tolerance Interval Estimates (PDF)
Reconsidering Shelf Life: An Update from the PQRI Stability Shelf Life Working Group (Presentation Slides) (PDF)
Non-Clinical Statistics Conference: An Update from the PQRI Stability Shelf Life Working Group (Presentation Slides) (PDF)
Shelf Life Determination: The PQRI Stability Shelf Life Working Group Initiative (Presentation Slides) (PDF)
Proposed Methodology for Shelf Life Estimation (PDF)
New Approaches to Stability Testing (Presentation Slides) (PDF)

Meeting Minutes

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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)
Work Plan (PDF)
Study Protocol - Stage 1 (PDF)

Meeting Minutes

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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

Meetings Minutes

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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

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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

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MTC Working Groups

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)

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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)

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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.

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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)

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Aseptic Processing Working Group

Work Plan

Aseptic Processing Work Plan (PDF)

Meeting Minutes

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BTC Working Groups

Nanotechnology Work Group

Nanotechnology Environmental, Health, and Safety Research

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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.

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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.

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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)

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Immediate Release Oral Drug Products Working Group

Meeting Minutes

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