Certified Pharmaceutical GMP Professional Practice

Which of the following is considered a valid maintenance practice for pharmaceutical equipment?

1. Only cleaning as needed

2. Not documenting cleaning activities

3. Regular calibration and cleaning documentation

4. Ignoring the cleaning status of equipment

The correct answer is: Regular calibration and cleaning documentation

Regular calibration and cleaning documentation is a key maintenance practice for pharmaceutical equipment because it ensures that the equipment operates within specified parameters and maintains the integrity of the pharmaceutical products being manufactured. Calibration is essential for verifying that instruments and equipment perform accurately and are capable of producing reliable results. Cleaning documentation is equally important as it provides a record of when and how cleaning was performed, ensuring compliance with Good Manufacturing Practices (GMP). This practice helps prevent contamination and ensures that equipment is in a state of control, which is crucial for maintaining product quality and safety. Comprehensive documentation also facilitates audits and inspections, demonstrating adherence to regulatory requirements and internal protocols.