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

The pharmaceutical and biotech industries are asked to deliver medicines at faster speeds and lower costs, while continuing to improve compliance to ensure the safety and efficacy of the drugs. Therefore, organizations continuously need to change and adapt to meet this challenge. 

 

This involves a review of historical practices and implementing more efficient ones. These actions should provide at least the equivalent compliance to ensure companies understand the process associated with the strategy and the risk to the patient. 

 

Revalidation is required to remain compliant with regulations and, in some cases, because there is no other way to continuously monitor each system to ensure it remains validated. 

 

Typically, equipment and facilities are validated when facilities are built or when new equipment is purchased and installed. The challenge is how to demonstrate that these remain suitable for use, in a validated state, and compliant when they are in a state of continuous use and/or when changes are made? And what data and testing are required to support the validated state? 

 

This paper describes risk-based alternative strategies for defending the suitability of equipment and facilities requiring revalidation. These robust and risk-assessed approaches include real-time review, routine monitoring, and in-line/at-line alarms and measurements to help identify what data and testing are critical to assure the continued validated state of the equipment.  

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  • Create Date 23rd September 2022
  • DOI https://doi.org/10.46220/2022DS003
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