Certified Pharmaceutical GMP Professional Practice

Which of the following must be included in a written record of major equipment cleaning?

1. Date and time of each cleaning

2. Total number of batches produced

3. List of all personnel involved

4. Type of cleaning solution used

The correct answer is: Date and time of each cleaning

The inclusion of the date and time of each cleaning in a written record of major equipment cleaning is essential for several reasons. It provides a clear and auditable timeline of maintenance activities, which is critical for compliance with Good Manufacturing Practices (GMP). Keeping accurate records of when equipment was cleaned ensures that the cleaning process is conducted according to established frequency requirements and allows for tracking of cleaning history. This information is vital in case of any quality assurance investigations or product recalls, as it helps to demonstrate that proper cleaning protocols were followed and that equipment was maintained to prevent cross-contamination. Furthermore, it supports the verification and validation processes, allowing for assessments of cleaning efficacy over time. Although additional information like the total number of batches produced, a list of personnel involved, and the type of cleaning solution used can be useful in various contexts, they do not hold the same level of regulatory requirement as the date and time of cleaning. Ensuring that the cleaning records are complete with dates and times lays the foundation for operational consistency and compliance with regulatory standards in pharmaceutical manufacturing.