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 […]
Hosting a Regulatory Inspection – A Blueprint for Success
Regulatory inspections are high-stakes events that can determine a pharmaceutical company’s ability to operate, supply medicines, and maintain its reputation. A failed inspection can lead to warning letters, supply chain disruptions, license suspensions, or even product recalls. Being inspection-ready at all times is not just about compliance with Good Manufacturing Practice (GMP)—it’s about embedding a quality culture that stands up to scrutiny. Companies […]