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Contract Manufacturing Working Group
Quality risk management (QRM) of pharmaceuticals in the context of the industry’s increased use of contract manufacturing and analytical facilities located both in established and emerging markets for late stage development (Phase 3) and commercial manufacturing of APIs and drug products is an area of increasing focus for the pharmaceutical industry and regulatory authorities. The goal of the Contract Manufacturing Working Group is to develop Industry Best Practices for these activities.
To understand potential areas of risk, the Contract Manufacturing Working Group has surveyed IQ member companies about current QRM practices in the areas listed below. The Working Group will use the results of the survey to identify opportunities for improvement and alignment across the industry, and develop Best Practices. Results of the Working Group’s efforts will be shared with the pharmaceutical science and regulatory communities.
Topics Addressed by the IQ Contract Manufacturing Survey
Quality Control
- General approaches to quality risk management for the manufacture of API’s, DP’s, API starting materials and intermediates, excipients and other components (including re-packaging, milling and contract sterilization).
- Approaches employed in the selection of contract manufacturing sites
- Quality oversight of Contract Manufacturing Sites and best practices for auditing CMO’s, including assessment of skill sets required for audit purposes
- Management of change and lifecycle approaches
- Documentation of supply chain and tracking systems
Technology and Maintenance
- Assessment of CMO scientific capability for effective technical transfer and execution of manufacturing
- Understanding and implementation of Quality-by-Design principles and approaches
- Mechanisms for bi-directional transfer of learning between the CMO and pharmaceutical organization
- Approaches employed in the selection of contract manufacturing sites
Survey results are available to IQ Consortium participants. You must be logged in to view the survey results.