MOVEMENT OF BATCH DOCUMENTS

Description

Batch documents, like the Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR), are essential in pharmaceutical manufacturing for ensuring product quality and compliance. These documents meticulously record every stage of production, from raw material receipt to final product release. Their movement throughout the manufacturing process is strictly controlled and documented to maintain traceability and accountability.

The BMR typically originates in Quality Assurance (QA), where it’s issued to Production upon receiving a manufacturing order. It then moves to Stores for raw material dispensing, Production for manufacturing operations, and Quality Control (QC) for analysis and testing. After QC approval, the BMR, along with other relevant documents, is archived in a secure location for future reference and regulatory audits.

Similarly, the BPR documents the packaging process, including packaging material checks, filling, sealing, and labeling.

Its movement follows a similar path, involving QA, Packaging, QC, and finally, archiving. This meticulous tracking of batch documents is crucial for ensuring product quality, safety, and regulatory compliance in the pharmaceutical industry.