Flair Pharma The Knowledge Kit.
Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
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
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 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
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
Operational Qualification Protocol for Building Management System (BMS)
The Master Formula Record (MFR) is the backbone of pharmaceutical manufacturing. It dictates “what to make, how to make it, and what standards to meet.” Crafting an MFR is not merely a documentation exercise; it’s an orchestration of science, compliance, and process integrity. Below is a uniquely structured representation of how an MFR is prepared … Read more
