The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction. JohanSwanepoel - Stock.Adobe.com Editor’s Note: This article ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...