Validation in the Life Sciences Industry: A New Risk-Based Approach

The ongoing SARS-CoV-2 (Covid-19) pandemic has highlighted the critical role that the pharmaceutical and life sciences industries play in maintaining a healthy society by developing lifesaving drugs, preventative treatments, and medical devices. Recent news on vaccine trials has also heightened our awareness to the importance of ensuring pharmaceutical products are safely produced and delivered to patients.

 

The core principle of validation in these critical industries is that evidence must be gathered to document that a system or solution operates as intended in a fully repeatable and accurate manner. CXV Global’s Validation and Compliance Services focuses on working with our valued clients to guarantee that solutions are fully validated following applicable regulatory requirements through a risk-based approach. In this approach, we emphasize three areas: System Risk Assessments, Levels of Criticality, and Logical Qualification Scopes.

 

In the initial stage(s) of projects, CXV Global can perform a System Risk Assessment and assess whether a system or sub-system is considered a Direct Impact or Indirect Impact System. The differentiating factor is whether or not a given design element poses any risk or impact to product quality. For example, a machine vision system that verifies the accuracy of printed barcode information plays a critical role in product quality. In contrast, a card reader system controlling access to a GMP environment may be classified as an Indirect Impact System depending on how a plant determines user privileges.

 

Once a system is classified as a Direct Impact System, the next goal is to define the level of criticality for the identified requirements. While no specific methodology is required, a typical approach often defines specifications as “Critical” or “Non-Critical,” where Critical items are referred to as Critical Quality Attributes (CQAs). Subsequent Critical Design Elements (CDEs) and Critical Process Parameters (CPPs) further specify how the CQAs are met in order to mitigate risk.

 

Finally, CXV Global aims to qualify our systems with a logical scope that focuses on testing those CQAs that impact product quality. Essentially, CXV Global emphasizes testing what NEEDS to be tested during FATs, SATs, and IOQs to save time, money, and resources to increase productivity and efficiency. Our risk-based approach cuts out the fat of unnecessary verification testing and ensures that any design element or configuration that impacts product quality is fully tested and validated.

 

As part of our approach, CXV Global offers both a traditional paper-based validation strategy as well as a newly developed partnership with Kneat to offer a digital validation. Stay tuned for a future blog on how CXV Global manages the digital validation process!

For more information contact a member of our sales team today