The pharmaceutical and biotech industries are asked to deliver medicines at faster speeds and lower costs – while continually improving compliance to ensure the safety and efficacy of finished products. Adapting to this model involves reviewing historical practices and implementing more efficient ways of working.
Validating equipment and facilities is typically done when facilities are built, or new equipment is purchased and installed. Demonstrating that these remain suitable for use, validated, and compliant when they are in continuous use, or each time changes are made, can be challenging. What data and testing are required to maintain the validated state?
These questions and more are answered in a new BioPhorum paper, Risk-Based Strategies to Support Revalidation and the Assessment of Requirements to Maintain the Validated State of Equipment, Process, and Facilities Used for Commercial and Clinical Manufacturing.
While the paper does not include all revalidation needs for all facilities, processes, and equipment, it includes concepts that can be extrapolated across a range of equipment, processes, cleaning methods, and systems. The paper looks at:
- New product introduction (equipment, process, and cleaning)
- Hold times
- Controlled temperature chambers
- Sterilization processes and equipment
- Periodic review.
The paper describes risk-based alternative strategies, so you can defend the suitability of your equipment and facilities requiring revalidation. These robust approaches include real-time review, routine monitoring, and in-line/at-line alarms and measurements. It will also help you identify what data and testing are critical to assure the continued validated state of your equipment.
“This is a great testament to the power of industry collaboration,” said Michael Parks, Director, Regulatory GCMC Vaccines at Pfizer and lead author of the paper. “It is a great collection of real-life, proven examples from across multiple companies that people can implement immediately after reading.”
Revalidating and demonstrating an appropriate state of control over time is required to maintain GxP processes and systems. Standard choices are either do everything and test everything or do everything and test less. Or you can use this BioPhorum paper to define appropriate policies and strategies to ensure your testing is risk-based so you can defend the quality, compliance and supply reliability of the products provided to patients.
The revalidation best practices described in this paper are a collection of concepts and processes used successfully across our industry. There may not be a one-size-fits-all approach to revalidation, but many of these practices can streamline and focus your revalidation requirements on those offering the most value – so you can avoid testing and creating documentation for no positive gain.
By taking the time to define your equipment controls up-front, rely on data, and use scientific understanding, you can set your organization up with a simple, compliant, and valuable revalidation strategy.