Certified Pharmaceutical GMP Professional Practice

What is essential for the production and process controls in drug manufacturing?

1. Documentation should only happen if there are issues

2. Critical steps must be documented as they occur

3. Mixing time can be recorded later

4. Deviations do not need to be recorded

The correct answer is: Critical steps must be documented as they occur

For effective production and process controls in drug manufacturing, it is essential for critical steps to be documented as they occur. This practice ensures traceability and accountability throughout the manufacturing process. By documenting critical steps in real-time, manufacturers are able to maintain accurate records that can be referenced during audits, inspections, and investigations. This documentation not only aids in ensuring product quality and safety but also plays a vital role in compliance with Good Manufacturing Practices (GMP). Additionally, documenting critical steps as they happen helps identify any variations or potential issues immediately, allowing for timely corrective actions. This proactive approach can significantly reduce the risk of errors and enhance overall operational efficiency, as opposed to waiting until later stages for documentation, which could lead to gaps in data and oversight. Overall, real-time documentation of critical steps is a fundamental aspect of maintaining high standards in pharmaceutical manufacturing.