This page includes information about each PQRI Technical Committee and provides links to the minutes recorded from all committee meetings. For more information about each Working Group, please click here.
Please note the NEW Technical Committee Structure at PQRI.

Announcement: Technical Committee Restructuring and Solicitation of Members for New Technical Committee (PDF)

Development Technical Committee
Drug Product Technical Committee
Drug Substance Technical Committee
Manufacturing Technical Committee
Biopharmaceutics Technical Committee

DTC Working Groups (WGs) focus on research projects that help to more clearly define through technical examples and applications the Quality by Design (QbD) concepts.

DTC Meetings Minutes

• January 17, 2008 (PDF)

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DPTC Working Groups (WGs) address issues of regulation and standards for finished drug products.

• The RFID WG is looking at implications of using radio-frequency identification devices on boxes containing pharmaceutical products.
• The Container/Closure Systems WG is developing test methods and evaluation criteria in support of FDA's PACPAC guidance.
• The Excipients WG is developing current practices for control of excipients and will explore ways for more efficient controls.
• 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.
• 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.
• The Leachables and Extractables WG is developing reporting and qualification thresholds for leachables in orally inhaled and intranasal drug products.

DPTC Meetings Minutes

• June 11, 2007 (PDF)
• April 5, 2007 (PDF)
• March 5, 2007 (PDF)
• December 12, 2006 (PDF)
• September 27, 2006 (PDF)
• August 2, 2006 (PDF)
• June 29, 2006 (PDF)
• May 11, 2006 (PDF)
• March 31, 2006 (PDF)
• February 10, 2006 (PDF)
• January 25, 2006 (PDF)
• December 1, 2005 (PDF)
• November 4, 2005 (PDF)
• October 17, 2005 (PDF)
• July 13, 2005 (PDF)
• June 8, 2005 (PDF)
• May 18, 2005 (PDF)
• November 3, 2004 (PDF)
• September 8, 2004 (PDF)
• August 11, 2004 (PDF)
• May 12, 2004 (PDF)
• February 11, 2004 (PDF)
• December 17, 2003 (PDF)
• October 22, 2003 (PDF)
• July 23, 2003 (PDF)
• May 14, 2003 (PDF)
• March 11, 2003 (PDF)
• October 23, 2002 (PDF)
• August 14, 2002 (PDF)
• June 25, 2002 (PDF)
• May 29, 2002 (PDF)
• April 25, 2002 (PDF)
• February 28, 2002 (PDF)
• December 12, 2001 (PDF)
• November 7, 2001 (PDF)
• October 16, 2001 (PDF)
• August 14, 2001 (PDF)
• July 17, 2001 (PDF)
• May 15, 2001 (PDF)
• April 17, 2001 (PDF)
• March 13, 2001
• February 20, 2001
• January 16, 2001

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DSTC Working Groups (WGs) deal with regulatory and scientific issues in the area of drug substance.

• The Impurities WG is determining appropriate methods and extent of characterization for impurities as a function of the stage of product development.
• The Physical Attributes/ Particle Size WG is discussing test methods and specification-setting for particles of active pharmaceutical ingredients in oral dosage forms.
• 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.

DSTC Meetings Minutes

• December 6, 2001

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The mission of the Manufacturing Technical Committee is to leverage our Manufacturing Expertise to define science-based approaches that appropriately integrate risk assessment and will encourage innovation and continuous quality improvement in pharmaceutical manufacturing and flexibility in the associated regulatory processes.

MTC Working Groups (WGs) address issues of regulation and standards for pharmaceutical manufacturing.

• The Process Robustness WG is developing an industry-wide understanding of factors that influence complexity and robustness of processes for oral solid dosage forms.
• 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.
• 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.
• The Biologicals Inspection Survey WG will evaluate and assess Team Biologicals inspections by conducting a survey of industry.
• Future WGs being worked on include Specification Design and Lifecycle Management, Biological Indicators for Use in Isolator Systems and Implementation of PAT.

MTC Meetings Minutes

• February 14, 2008 (PDF)
• May 17, 2007 (PDF)
• April 19, 2007 (PDF)
• March 15, 2007 (PDF)
• February 15, 2007 (PDF)
• June 10, 2005 (PDF)
• February 3, 2005 (PDF)
• September 30, 2004 (PDF)
• August 26, 2004 (PDF)
• May 27, 2004 (PDF)
• January 22, 2004 (PDF)
• June 19, 2003 (PDF)

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The PQRI BTC Working Groups (WGs) deal with regulatory and scientific issues associated with the following areas of biopharmaceutics:

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

BTC Meetings Minutes

• February 12, 2003 (PDF)
• January 22, 2003 (PDF)
• September 27, 2002 (PDF)
• August 13, 2002 (PDF)
• June 27, 2002 (PDF)

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