Certified Pharmaceutical GMP Professional Practice

What is included in the component, drug product container, closure, and labeling records?

1. Supplier's country of origin

2. Results of any tests performed

3. Retail price of the product

4. Shipping intervals

The correct answer is: Results of any tests performed

The inclusion of results from any tests performed in the component, drug product container, closure, and labeling records directly correlates with the requirements for ensuring product quality, safety, and efficacy within pharmaceutical manufacturing. These records serve as critical documentation that reflects whether the components and materials used have met established specifications and compliance standards. Testing results provide evidence of quality control measures and help verify that all components, including primary packaging and labeling, are suitable for their intended use. This ensures that any potential issues related to contamination, stability, or incorrect labeling are identified and addressed before the product reaches the market. Having documented test results is essential for compliance with current Good Manufacturing Practices (cGMP) regulations, as it allows for traceability and accountability in the manufacturing process. While supplier's country of origin may be relevant for traceability or regulatory compliance, it does not specifically relate to the testing and quality assurance aspect required in these records. Similarly, retail price and shipping intervals are logistical topics that lie outside the scope of component and product records focused on quality and testing outcomes.