Certified Pharmaceutical GMP Professional Practice

For laboratory records, what must be included regarding testing methods?

1. A statement of each method used

2. Names of all laboratory staff

3. A budget for ongoing tests

4. Details of similar tested products

The correct answer is: A statement of each method used

Including a statement of each method used in laboratory records is crucial for ensuring compliance with Good Manufacturing Practices (GMP). This requirement is focused on providing transparency and facilitating reproducibility in testing procedures. A clear and detailed description of the methods allows anyone reviewing the records to understand the protocols that were followed, assess their validity, and evaluate the reliability of the results obtained. It supports the integrity of the laboratory work and helps in troubleshooting any issues that may arise during testing or when analyzing results. Other options, while potentially relevant to laboratory operations, do not directly address the fundamental requirements regarding testing methods. For instance, knowing the names of all laboratory staff is important for tracking accountability but does not pertain to the actual testing methods employed. Similarly, budgeting for ongoing tests is critical for financial planning but does not affect the technical standards of method documentation. Lastly, details of similar tested products may provide context but are not essential for documenting each method used, which is mandated for regulatory adherence and scientific rigor.