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Showing posts from September, 2025

Granulation in Pharmaceutical Manufacturing: Challenges, Remedies, KPIs, and In-Process Parameters

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

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 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...