For breakthrough product development, Pharmaceutical Quality System (PQS) requirements need to be followed while supplying suitable flexibility to suit accelerated activities for breakthrough product development timelines. Therefore, the accelerated development Pharmaceutical Quality System (PQS) strategy for each product will be unique, as it depends on the timing of the BT designation.
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A number of activities that might be considered to accelerate development activities are:
- Flexibility, on the basis of molecule, available product, and platform knowledge will be needed
- Just the activities with zero impact on patient safety or product supply should be delayed
- A quality risk assessment needs to be applied to every activity that will be delayed, and the rationale, and controls required to guarantee delayed activities are completed documented
- A number of activities that are usually completed before license application might need to be delayed and submitted:
- Post-submission, complete at inspection
- Post-inspection, before approval
- Post-market commitments
- The manufacturing readiness plan can be employed for the development of internal filing and inspection readiness checklists to safeguard all delayed activities are completed or addressed
- Any Pharmaceutical Quality System (PQS) deferrals need to be documented in a manufacturing readiness plan and monitored to guarantee completion
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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