Certified Pharmaceutical GMP Professional Practice

What role must the quality control department maintain in relation to the production department?

1. Act as a support team

2. Maintain independence

3. Be involved in production decisions

4. Operate under the production manager

The correct answer is: Maintain independence

The quality control department must maintain independence from the production department to ensure objective evaluation and oversight of processes and products. This independence is crucial as it allows quality control to provide an unbiased assessment of production practices, materials, and final products, which is essential for maintaining compliance with regulatory standards and ensuring product safety and efficacy. When quality control operates independently, it enhances the integrity of quality assessments and helps prevent any potential conflicts of interest that may arise if it were directly involved in production decisions or managed by production personnel. This delineation of roles is a foundational principle of Good Manufacturing Practices (GMP), which emphasizes the need for clear separation between production and quality control functions to uphold high product standards.