Process of validating a will
As with any manufacturing process, conditions in the environment or human factors can vary and this can affect product quality.
Before commercialization, it is important to discern and mitigate as many of these risks as possible.
Depending on your regulatory requirements, Biocoat can craft a Process Validation protocol that is robust and defendable.
Not only must the equipment used to coat devices work consistently, but the medical device manufactured must also be of consistent quality and perform to specification.Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing.More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities.Regulatory framework of legacy product Legacy products are believed to be experiencing some kind of “new life” in the pharmaceutical market.
The lack of new molecules and the challenges in registering new products, due to increasingly stringent requirements from preclinical and clinical through to registration phases, are driving many pharmaceutical companies to revamp old products in their portfolio.The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidelines on process validation (1, 2).