Blogs #quality standards
Quality Assurance (QA) vs. Quality Control (QC): Understanding their 9 Crucial Contrasts in Pharmaceuticals and Medical Devices
Quality in regulated industries refers to the degree to which a product or process meets predefined standards and regulatory requirements.
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.