Blogs #pharmaceutical industry
Annex 1 Revisions: Understanding the Implications of European Commission's Updates
Annex 1 of the European Union GMP document provides specific guidance on the production of sterile medicinal products, covering various aspects such as facilities, equipment, validation, environmental monitoring, and personnel. Its aim is to establish a harmonized approach to ensure the highest quality standards throughout the manufacturing process.
Exploring Analytical Method Validation and Untangling Verification vs. Validation
This blog explores Analytical Method Validation (AMV) in the pharmaceutical industry, covering its stages and differentiating between verification and validation. It emphasizes the importance of AMV for ensuring accurate and reliable analytical methods. By following method development, qualification, and validation stages, pharmaceutical companies can maintain product quality and compliance.