PHARMA KING ACE

  Introduction In the pharmaceutical industry, when a deviation occurs, we cannot simply "fix and forget." Regulatory bodies like the USFDA and WHO demand that we find out why the failure happened at its deepest level. This process is called Root Cause Analysis (RCA). If your RCA is weak, your CAPA (Corrective and Preventive Action) will fail, leading to recurring deviations and potential FDA 483 warning letters. In this post, we explore the purpose, regulatory references, and top methods for effective RCA. Purpose of Root Cause Analysis The primary goal of RCA is to identify the underlying cause of a problem rather than just treating the visible symptoms. Prevent Recurrence: Ensuring the same error doesn't happen twice. Process Improvement: Identifying systemic weaknesses in manufacturing or quality. Regulatory Compliance: Meeting the expectations of international health authorities. Patient Safety: Ensuring every batch of medicine meets the required purity and potency....

  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...