ALCOA is a set of principles (Alcoa Principles) that ensure the integrity of data, particularly important in the life sciences sector. It’s used by the FDA (Food and Drug Administration) and is becoming increasingly crucial for Good Manufacturing Practices (GMP). In the realm of pharmaceuticals, maintaining accurate and reliable data is not just a regulatory … Read more
Purpose: The purpose of this SOP is to establish comprehensive guidelines for the effective implementation of the Quality Management System (QMS) in compliance with ISO 17025 and Current Good Manufacturing Practices (cGMP) regulations in the pharmaceutical industry. Scope: This SOP applies to all personnel involved in testing and calibration activities within the pharmaceutical laboratory, ensuring … Read more
In the fast-paced world of pharmaceuticals, maintaining uncompromising quality is not just a regulatory requirement but a cornerstone of trust and reliability for healthcare providers and patients alike. A robust Quality Management System (QMS) stands as a crucial tool in achieving and sustaining these high standards. This blog post aims to provide a comprehensive guide … Read more
