Certified Pharmaceutical GMP Professional Practice

Which of the following must be included in receiving records of components?

1. Type of storage container

2. Manufacturer's lot number and control number

3. Date of delivery only

4. Component weight only

The correct answer is: Manufacturer's lot number and control number

Including the manufacturer's lot number and control number in receiving records of components is essential for several key reasons. These identifiers provide traceability, ensuring that each component can be tracked back to its source, which is crucial for quality assurance and compliance with Good Manufacturing Practices (GMP). The lot number indicates a specific batch of product, which can help identify potential issues if a defect or contamination is detected in the future, allowing for effective recalls or investigations. In regulated environments like pharmaceuticals, maintaining accurate records that include this information is a requirement to demonstrate compliance with regulatory standards. The ability to trace back materials to their original manufacturing source ultimately enhances product safety and efficacy, and it is vital for maintaining an effective quality management system. This attention to detail in documentation helps to uphold the integrity of the manufacturing process and ensures that finished products meet safety and efficacy standards for patients.