Certified Pharmaceutical GMP Professional Practice

What must equipment undergo regularly to ensure proper function?

1. Periodic cleaning as needed

2. A single annual inspection

3. Calibration on a monthly basis

4. Regular calibration and maintenance

The correct answer is: Regular calibration and maintenance

Regular calibration and maintenance of equipment are essential practices in the pharmaceutical industry to ensure accuracy, reliability, and compliance with Good Manufacturing Practice (GMP) standards. Calibration involves adjusting and verifying the precision of measurement devices to ensure they provide accurate results. Over time, equipment can drift from its calibrated settings due to wear and tear, environmental factors, or other variables that affect performance. Regular maintenance helps identify potential issues before they lead to equipment failure, ensuring that instruments and systems remain in good working order and operate as intended. This combination of calibration and maintenance creates a robust quality assurance framework, helping to minimize risks associated with product quality and ensuring compliance with regulatory requirements. Failing to regularly calibrate and maintain equipment could lead to inaccurate data, which can ultimately affect product safety and efficacy. Therefore, adhering to a schedule of regular calibration and maintenance is critical for any facility involved in pharmaceutical manufacturing.