Managing Deviations in Pharma: Step-by-Step Guide
Managing Deviations in Pharma Manufacturing: Step-by-Step Guide In a highly regulated pharmaceutical industry, product quality and patient safety cannot be compromised. Deviations are those incidents which may include an unexpected error or irregularities that take place during the course of operations even when strict GMP guidelines are being followed. An effective pharmaceutical deviation management system […]
The Role of the Qualified Person in the Pharmaceutical Supply Chain – The Gatekeeper of Quality and Compliance
The Qualified Person (QP) plays a critical role in pharmaceutical supply chains, acting as the final gatekeeper to ensure that every batch of medicine released meets regulatory and quality requirements. The QP is legally responsible for ensuring that medicinal products comply with Good Manufacturing Practice (GMP) and that patient safety is always the top priority. Beyond batch release, the QP’s role […]