Certified Pharmaceutical GMP Professional Practice

Which of the following is a requirement for equipment logs?

1. Logs can be kept in electronic form only

2. Individuals must sign off on completed cleaning

3. Logs are optional for dedicated equipment

4. Only a summary of equipment use is required

The correct answer is: Individuals must sign off on completed cleaning

The requirement for individuals to sign off on completed cleaning is essential for maintaining compliance with Good Manufacturing Practices (GMPs). This practice ensures traceability and accountability in the cleaning process of equipment. By requiring a signature, it verifies that a specific task has been completed properly, indicating that the equipment is ready for use in production without the risk of contamination. This documentation is critical in a regulated environment, as it provides a record that can be audited to confirm that cleanliness standards have been met before equipment is utilized again. Maintaining accurate equipment logs that include cleaning verification helps ensure product quality and safety, which are foundational principles of GMP. Proper documentation supports regulatory compliance and could be crucial in investigating any issues related to product quality that arise later in the process.