Certified Pharmaceutical GMP Professional Practice

What aspect of production records is reviewed by the quality control unit?

1. Market pricing information

2. Shipping logistics

3. All discrepancies or failures

4. Employee performance

The correct answer is: All discrepancies or failures

The quality control unit plays a critical role in ensuring that pharmaceutical products meet predefined quality standards. One of their key responsibilities is to review production records meticulously, focusing primarily on all discrepancies or failures that arise during the manufacturing process. This is essential for maintaining compliance with Good Manufacturing Practices (GMP) and ensuring the safety and efficacy of pharmaceutical products. When discrepancies or failures are identified, they could indicate issues such as deviations from standard operating procedures, problems with equipment, or raw material inconsistencies. The quality control unit must investigate these issues thoroughly to determine their impact on the product and ensure that corrective actions are taken to prevent recurrence. This proactive approach helps to maintain product integrity and protects public health. In contrast to the correct answer, other aspects like market pricing information, shipping logistics, and employee performance may be important for the overall functioning of a pharmaceutical organization but do not fall under the direct purview of the quality control unit in terms of production record review. The primary mandate of the quality control unit is to safeguard product quality and compliance, making the review of all discrepancies or failures central to their responsibilities.