Process Validation Lifecycle Implementation for Existing Products
David D. Dolgin
The global pharmaceutical industry has been involved in a period of transformational change over approximately the last decade, moving from traditional product development methods and Pharmaceutical Quality Systems (PQS) towards holistic and patient-risk-based approaches to knowledge and lifecycle management as described by ICH Q8, Q9 and Q10. For the most part, this new focus on science, process control and patient risk has impacted the development and initial process validation expectations for new products, however there are also newly articulated regulatory expectations for “ongoing”, or “continued”, process verification during the entire commercial life of a pharmaceutical product. For many firms, especially small to mid size manufacturers, the most urgent issues in aligning with the new process validation lifecycle are not about new products at all, but rather center around the ongoing verification of existing, or “legacy”, products. Some of the common questions that arise include:
What quality attributes are expected to be monitored on an ongoing basis?
How much data do we need to monitor?
What if a process is not in statistical control?
Do we need to “reverse-engineer” development to enable ongoing monitoring of a legacy product?
In an attempt to provide a multi-company view of these and other issues, the ISPE PV Team has drafted a paper addressing the concerns of firms attempting to implement the Process Validation Lifecycle generally and the Ongoing Process Verification phase specifically. Led by Senior Quality Managers from industry leading companies, the paper presents perspectives on both company-wide and individual-product strategies. It may be problematic for firms to simply increase all monitoring of all attributes to “statistical” levels, especially if there is not a well developed knowledge base and PQS to support the enhanced monitoring’s implementation. A “roadmap” to implementation may be needed. This paper is intended to help plan that journey for legacy product firms. Download the Process Validation Lifecycle Implementation for Existing (“Legacy”) Products discussion paper today!
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