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.

Working Plans

• Process Robustness Work Plan (PDF)

• Aseptic Processing Work Plan (PDF)

All Minutes: http://www.pqri.org/commworking/minutes.asp