Documentation
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
Design Basis Document of HVAC in Pharma
Design Basis Document of HVAC genrated when we start designing new fecility for the Pharmaceutical plant. This guide outlines critical cleanroom classifications, regulatory compliance (GMP, WHO, ISO), pressure cascades, and design criteria to ensure air quality, product safety, and operational efficiency in your new plant. M/s. Flair Pharma, Panchkula, HaryanaOSD Block, OSD Liquid Block, LAB Area, … Read more
The Future of Pharma: How AI and Machine Learning are Optimizing Batch Records Review
Discover how ai machine learning batch record review is revolutionizing pharmaceutical quality control. This in-depth article explores how AI and ML automate compliance, accelerate release times, predict deviations, and ensure drug safety, paving the way for the future of pharma manufacturing. For anyone on the floor of a pharmaceutical manufacturing unit, the batch record is the heartbeat … Read more
How to Calculate and Interpret OOS (Out-of-Specification) Results: A Step-by-Step Guide
Encountering an Out-of-Specification (OOS) result is a high-pressure event in any pharmaceutical quality control laboratory. It signals that a product batch may not meet its predefined quality standards, potentially impacting patient safety and triggering regulatory scrutiny. A structured, compliant investigation is not just a best practice—it’s a regulatory requirement. This step-by-step guide will walk you through … Read more
Fumigation Validation in Cleanroom Areas
Fumigation Validation is the key validation in the heart of sterile pharmaceutical manufacturing, where microscopic intruders threaten product safety, cleanrooms serve as the ultimate guardians. But even these sanctuaries demand periodic deep decontamination. Among the most powerful tools in the contamination control arsenal is fumigation—a process where a disinfectant in gaseous or vaporized form eliminates … Read more
Preparation of Batch Packaging Record (BPR) in Pharmaceuticals
Introduction: The BPR Blueprint Begins Here Preparation of Batch Packaging Record (BPR) in the pharmaceutical world is important, where every pill and package matters, there exists a silent but essential guardian of compliance—the Batch Packaging Record (BPR). But before it documents anything on the production floor, it must first be designed, compiled, and approved. This … Read more
Good Documentation Practice (GDP) :(Requirements ,principles ,Advantages and disadvantages )
Good Documentation Practice