Documentation
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
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
Operational Qualification Protocol for Building Management System (BMS)
Operational Qualification Protocol for Building Management System (BMS)
Preparation of Master Formula Record (MFR)
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
Design Qualification (DQ)in Pharma
Definition: Design Qualification (DQ) is a documented verification process that ensures the proposed design of facilities, systems, or equipment is suitable for the intended purpose, meets all user requirements, and complies with regulatory expectations (e.g., cGMP, FDA, EU-GMP, ISO). DQ confirms that the design outputs (drawings, layouts, specifications) align with the defined user and quality … Read more