Certified Pharmaceutical GMP Professional Practice

What must be specifically documented in Batch Production Records?

1. All raw materials used

2. Each significant step in manufacture

3. Employee training records

4. Quality control test results

The correct answer is: Each significant step in manufacture

The documentation of each significant step in manufacture is crucial in Batch Production Records (BPR) as it provides a detailed account of the entire production process. This includes recording the specific procedures followed, the equipment used, and any deviations from standard operating procedures (SOPs). Documenting these steps ensures that the manufacturing process can be replicated consistently, which is a fundamental requirement of Good Manufacturing Practices (GMP). It allows for traceability and accountability, which are vital for ensuring product quality and safety. While raw materials used, employee training records, and quality control test results are also important in the context of pharmaceutical production, they are typically recorded in other relevant documentation or specific records. For instance, raw materials are often documented in Material Specifications or in the Inventory Management system, while employee training records are maintained separately in HR or training files. Quality control test results are typically found in Quality Control records rather than in the BPRs themselves. Therefore, the focus of BPRs is on the manufacturing process, making documentation of each significant step essential for compliance with regulatory standards.