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...

Granulation in Pharmaceutical Manufacturing: Challenges, Remedies, KPIs, and In-Process Parameters Granulation is one of the most critical processes in pharmaceutical manufacturing, especially in the production of oral solid dosage forms (OSD) such as tablets and capsules. It plays a decisive role in ensuring content uniformity, compressibility, flowability, dissolution, and stability of the final product. A poorly designed or controlled granulation process can lead to batch failures, weight variation, poor hardness, friability issues, and dissolution failures, which not only affect Good Manufacturing Practices (GMP) compliance but also increase the cost of production. In this detailed article, we will explore: The importance of granulation in pharma manufacturing Key challenges faced during granulation Practical remedies and solutions to overcome those challenges Key Performance Indicators (KPIs) to measure granulation efficiency Crucial In-Process Control (IPC) parameters to monitor ...

In-Process Quality Control (IPQC) Tests for Tablets – A Complete Guide. Introduction In the pharmaceutical industry, quality is non-negotiable . Tablets remain the most common dosage form, and ensuring their safety, efficacy, and uniformity is essential. To achieve this, In-Process Quality Control (IPQC) tests for tablets are conducted during different stages of manufacturing. Unlike finished product testing , which happens after the batch is complete, IPQC tests are performed during production . These checks help detect problems early, reduce wastage, maintain compliance with Good Manufacturing Practices (GMP) , and ensure consistent quality. This guide explains all IPQC tests for tablets , their purpose, procedure, acceptance criteria, and regulatory significance in detail. What is IPQC in Pharmaceuticals? In-Process Quality Control (IPQC) refers to the checks and tests performed at different stages of manufacturing to ensure that intermediate and final products meet t...

Batch Technology Transfer from F&D to Production in Pharmaceutical Industry Batch Technology Transfer from F&D to Production in Pharmaceutical Industry In the pharmaceutical industry, technology transfer is a critical step that bridges the gap between formulation and development (F&D) and commercial manufacturing . It ensures that the knowledge, processes, and controls established during research and development are successfully transferred to the production floor without compromising on quality, safety, and efficacy . What is Technology Transfer? Technology Transfer (TT) refers to a systematic procedure that transfers documented knowledge, skills, processes, and analytical methods from the sending unit (F&D) to the receiving unit (Production/Manufacturing) . It is a key activity during the product life cycle and is regulated under multiple global quality guidelines. Regulatory...

5S in Pharmaceutical Industry: Steps, GMP Compliance, Benefits & Implementation GMP • Lean • QA 5S in Pharmaceutical Industry – Implementation, Benefits & Guidelines Learn how to apply 5S (Seiri, Seiton, Seiso, Seiketsu, Shitsuke) to boost GMP compliance , strengthen data integrity , and improve productivity in pharma manufacturing and QC labs. 5S Circle for Pharmaceutical Industry A circular diagram showing five equal segments labeled Seiri, Seiton, Seiso, Seiketsu, and Shitsuke. 5S Pharma • GMP • Lean ...