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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
Manufacturing Technical Committee
Biopharmaceutics Technical Committee

Development Technical Committee (DTC)

The DTC was created by combining the DPTC and DSTC. 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

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Current Work Groups

Past Work Groups

The former 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.

The former 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.

DPTC Meetings Minutes

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DSTC Meetings Minutes

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Manufacturing Technical Committee (MTC)

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

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Biopharmaceutics Technical Committee (BTC)

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

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