The mission of the Product Quality Technical Committee (PQTC) 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. PQTC Working Groups (WGs) address issues of regulation and standards for pharmaceutical manufacturing. For more information about the MTC, see the attached flyer.
Copies of PQTC Minutes are available upon request. Please contact the PQRI Secretariat for copies of minutes.
Reports and White Papers are available at Publications.
- Current Working Groups
- Elemental Impurities Study – Conducting EI research to investigate variability of ICP-MS analysis of elemental impurities.
- Topical Drug Classification System (with PQRI BTC) – Webinar held on April 9, 2018, click here for webinar recording.
- Disinfectant Coupon Testing – Developing guidance in regards to the need and value of performing site
specific coupon testing for disinfectant qualification.
- Emerging Projects
- Cleaning Validation/Testing
- Definition of Lot and Discard Approaches in Continuous Manufacturing
- Past Projects
- Elemental Impurities Workshop – The third workshop was held in November 2017 to share industry experiences with implementation of the ICH Q3D guideline. Click here to access the presentations.
- The Process Robustness WG developed a White Paper on process robustness concepts and how it applies to development, scale up, and manufacture of pharmaceutical products.
- Post Approval Changes for Sterile Products WG published a report providing regulatory CMC information relevant to development of a Post Approval Guidance for Sterile Drug Products for Human, Veterinary, and Well Characterized Biological Products.
- The Case Studies for Risk Management WG developed case studies providing specific pharmaceutical examples using different QRM tools, and recommendations for which tools to use in different areas, and training guides.
- The Biologicals Inspection Survey WG surveyed the biological products manufacturing industry, with emphasis on inspection and compliance of program operations; published a report.
- The Specification Design and Lifecycle Management WG created a concept paper to stimulate discussion on processes and activities that occur from creation through development and commercialization of molecule to drug product.
- The Transdermals WG published an update to the 1997 SUPAC Transdermal White Paper to include QbD, PAT, and FDA and industry initiatives on development, scale-up, manufacture and control of transdermals.