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Understanding CAPA in Pharmaceutical Industry: A Complete Guide to GMP Compliance

  Introduction In the pharmaceutical industry, maintaining quality is not just a goal; it is a regulatory requirement. One of the most critical components of a Quality Management System (QMS) is CAPA (Corrective and Preventive Action). Whether you are preparing for a USFDA audit or a job interview, understanding the lifecycle of a CAPA is essential. In this guide, we will break down what CAPA is, the difference between Correction, Corrective Action, and Preventive Action, and how to implement it effectively. What is CAPA? CAPA stands for Corrective and Preventive Action. It is a systematic process used to investigate root causes of non-conformities (deviations, audit findings, or complaints) to prevent their recurrence. Correction: Immediate action taken to fix a detected non-conformity (e.g., cleaning a spill). Corrective Action (CA): Action taken to eliminate the cause of a detected non-conformity to prevent it from happening again. Preventive Action (PA): Action taken to elimina...