Zenovel Pharma Services LLP

GMP Audits Unveiled: Behind the Scenes of Ensuring Compliance

Understanding the role of GMP Audits and Its Importance Good Manufacturing Practices (GMP) are a set of guidelines and regulations that ensure products are consistently produced and controlled according to quality standards. GMP audits are comprehensive assessments conducted to verify whether manufacturers are complying with these established practices. They encompass various aspects such as facility… Continue reading GMP Audits Unveiled: Behind the Scenes of Ensuring Compliance

How to Prepare Subject Matter Experts for FDA Inspections

Introduction Facing an FDA inspection can be a nerve-wracking experience for any pharmaceutical company. While many focus on logistics and documentation, one crucial aspect that should not be overlooked is preparing your Subject Matter Experts (SMEs) for the inspection.  SMEs, who possess in-depth knowledge of your front-line operations, can unintentionally provide information that may harm… Continue reading How to Prepare Subject Matter Experts for FDA Inspections

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