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

Master Formulation Record

OPERATIONAL QUALIFICATION

Pillars of GDP

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)