Certified Pharmaceutical GMP Professional Practice

Records of laboratory testing must include initials or signatures of how many persons?

1. One person

2. Two persons

3. Three persons

4. Four persons

The correct answer is: Two persons

In the context of Good Manufacturing Practice (GMP) for the pharmaceutical industry, it is essential that records of laboratory testing provide clear accountability and traceability. The requirement for the initials or signatures of two persons stems from the principle of checks and balances designed to ensure accuracy and integrity in laboratory results. When two individuals review and sign off on laboratory records, it serves several important purposes: 1. **Accountability**: The first person, typically a technician or analyst, is responsible for conducting the testing and documenting the results. Their signature or initials confirm that they performed the work and recorded the findings accurately. 2. **Verification**: The second individual, often in a supervisory or quality assurance role, is responsible for reviewing the results and the documentation for accuracy, compliance with protocols, and proper methodology. Their initials or signature indicates that they have performed this verification process. This dual review system helps to minimize errors, increases reliability in test results, and fosters compliance with regulatory standards. It also aids in maintaining the overall quality control systems within pharmaceutical manufacturing, ultimately contributing to patient safety and product efficacy.