Process Verification (CPV)

March 05, 2015    Article

Compliance management is an ongoing challenge for life sciences companies. New technologies are making verification systems easier to implement, but the same advances in technology also make businesses that are not in compliance with FDA rules and regulations easier to identify.

An essential component of compliance management for a life science company is to implement a Continued Process Verification (CPV) program to ensure that issues are identified early in the process.

Process validation is a several stage process that includes the collection and evaluation of data. Information from the design stage through end product production to the supply chain must be gathered and maintained. This information is then evaluated to support the basis that establishes scientific evidence that a process is capable of consistently delivering quality products.

The FDA defines process validation as follows:

For purposes of this guidance, process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes process validation activities in three stages:

• Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through the development and scale-up activities.

• Stage 2 – Process Qualification: During this phase, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

• Stage 3 – Continued Process Verification: Ongoing assurance is gained through routine production that the process remains in a state of control.

The FDA recommends an integrated team approach as the best practice for CPV. The CPV team should include members from process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance. Senior management needs to not only offer full support to the work of the CPV team, but must be actively involved in the process.

Process validation must continue throughout the product lifecycle and be under constant review for changes in process. As new technology evolves, new studies should be implemented to evaluate any changes in the process. Federal 21 CFR 211.180(e) regulations require assessing and determining the need for change in manufacturing or control procedures on an ongoing basis.

Continued process verification makes sense from a business as well as a regulatory compliance standpoint. New technology in production, design and delivery often provides a more cost efficient methodology that reduces cost along the entire product chain. The FDA is supportive of new initiatives that provide for better service delivery, but also demands that the process be thoroughly validated to ensure the public good. An ongoing CPV makes changes easier to implement and ensures maintaining compliance with the FDA.