Are You Validating the Right Way?
Understanding the Validation Process: Different Approaches for Different Needs
When it comes to process validation, companies often take different approaches depending on their level of experience and existing documentation.
Some organizations have a clear idea of what they need to validate and how they want to approach it, while others may only know the product they want to manufacture but lack a structured validation plan. No matter where a company starts, the key is to align validation efforts with product claims, process settings, and regulatory requirements.
For companies at the beginning of their validation journey, the first step is to define the claims they are making about their process. This includes identifying the process parameters, determining how those parameters are documented, and ensuring they are clearly outlined before moving forward. Having a solid understanding of these elements upfront makes the later steps of validation much smoother.
Other companies may already have a defined validation strategy, including sample selection and testing methods. They may know exactly what they need to test to ensure compliance with regulatory standards. However, some organizations only focus on product testing for release and may not have a plan for validating the entire process. In these cases, guiding them through the qualification of a population of samples is essential to ensuring that the manufacturing process consistently produces a reliable product.
Regardless of the starting point, the goal of process validation is to provide documented evidence that a manufacturing process is capable of consistently producing a product that meets established specifications. By tailoring the approach to each company's specific needs, validation professionals can help ensure compliance, product quality, and overall manufacturing success.
Are you confident in your validation approach? Let’s discuss how to streamline your process. Schedule a call at meet.brayearst.com today!
