Continuous Process Verification per FDA Process Validation Guidance

by | Jan 19, 2012 | Industry, Life Sciences & Medical, Operations & Business Management

Process Validation GuidanceIt was just about a year ago that the U.S. Food and Drug Administration published their Guidance for Industry – Process Validation: General Principles and Practices. I caught up with Emerson’s Heather Schwalje, a senior consultant on the Life Sciences industry team. Heather shared key elements from this FDA process validation guidance document and how automation plays a significant role for pharmaceutical and biotechnology manufacturers.

The guidance document’s recommendations section D. Stage 3 ― Continued Process Verification states:

The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal. Adherence to the CGMP requirements, specifically, the collection and evaluation of information and data about the performance of the process, will allow detection of undesired process variability.

Heather noted that continuous and batch automation systems such as the DeltaV system, have control, alarm, and response capability for both batch and continuous process data. An example is the system’s ability to monitor and control the temperature on a bioreactor. The system records and stores exceptions in the production process through the event and history logs or in combination with an electronic batch record (EBR) system. These systems provide reconciliation and/or integration with deviation management systems.

Also in this same section of this document is stated [hyperlink added]:

An ongoing program to collect and analyze product and process data that relate to product quality must be established (§ 211.180(e)). The data collected should include relevant process trends and quality of incoming materials or components, in-process material, and finished products. The data should be statistically trended and reviewed by trained personnel. The information collected should verify that the quality attributes are being appropriately controlled throughout the process.

Heather shared that automation systems perform ongoing collection of critical process parameters through trending and historical data collection. Laboratory data can be collected on an ongoing basis when integrated with the EBR system. Some of the laboratory data may be eliminated via Process Analytical Technology (PAT) where feasible and appropriate. In an earlier post, Finding Process Analytical Technology Opportunities, I shared some thoughts on spotting these opportunities. Manual data entry, tracking, and reconciliation, historically done with databases and spreadsheets, can be significantly reduced through the integration of the automation system, EBR system, and enterprise resource planning (ERP)-based material transactions.

Finally, Heather highlighted the recommendation from this same section [hyperlink added]:

Maintenance of the facility, utilities, and equipment is another important aspect of ensuring that a process remains in control. Once established, qualification status must be maintained through routine monitoring, maintenance, and calibration procedures and schedules (21 CFR part 211, subparts C and D). The equipment and facility qualification data should be assessed periodically to determine whether re-qualification should be performed and the extent of that re-qualification. Maintenance and calibration frequency should be adjusted based on feedback from these activities.

The automation system provides ongoing collection of key utility and equipment performance parameters used for the analysis. Through a combination of smart, self-diagnosing process sensors and final elements connected with automation systems, asset management systems, and operations management systems, early predictive and proactive maintenance strategies can be applied to help achieve the spirit of these guidelines.


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