Switching Thermal Packaging Mid-Approval: What FDA Regulations Actually Require
A thermal packaging change during an approved or submitted commercialization state is a regulatory...
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How to Implement ISTA’s PCG-03 Recommendations
How to Implement ISTA’s PCG-03 Recommendations
On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline. PCG-03 takes the first steps toward standardizing best practices for PQ strategy and execution for the biopharmaceutical industry, as it is the first document to compile strategies from thought leaders in the industry and provide a path forward for transport validation work.
We applaud ISTA for this useful and comprehensive list of considerations for determining your PQ strategy. However, there remains a clear gap on how to manage and implement their recommendations. The items listed within the document require further context to enable the industry to form a cohesive approach to PQ strategy.
In this guide, the experts at Modality Solutions dive into the considerations listed by ISTA and discuss the implications and risks of each topic.
- Scoping and Timing
- Lane Bracketing
- Shipper and Payload Bracketing
- Monitoring
- Acceptance Criteria
- Management
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