Certified Pharmaceutical GMP Professional Practice

Which documentation must be included in batch production and control records?

1. A summary of product sales

2. A log of employee attendance

3. A record of each significant manufacturing step

4. A customer feedback report

The correct answer is: A record of each significant manufacturing step

The inclusion of a record of each significant manufacturing step in batch production and control records is essential for several reasons. This documentation provides a detailed account of all critical activities performed during the production process. It serves as a comprehensive audit trail, which is vital for ensuring that the manufacturing processes comply with Good Manufacturing Practices (GMP). By documenting each significant step, manufacturers can verify that processes were followed according to established protocols and specifications, allowing for traceability in case of any quality concerns or regulatory inspections. This detailed account also aids in identifying any deviations or issues that may arise during production, thus facilitating root cause analysis and corrective actions when necessary. Moreover, this record is instrumental in maintaining product quality and consistency. It enables manufacturers to ensure that every batch produced meets the required specifications before it is released for sale, thereby protecting patient safety and upholding product integrity in the market.