Cleaning Validation Checklist

I’m reviewing the status of cleaning validation. Here is the list I’m currently going through, just in case it helps others.

1. Develop a comprehensive cleaning validation master plan that outlines your overall approach, policies, and procedures for cleaning validation at your facility. This should cover all aspects of the cleaning validation lifecycle.
2. Ensure you have written standard operating procedures (SOPs) for equipment cleaning processes that address different scenarios (e.g., cleaning between batches, between product changes, etc.).
3. Have written cleaning validation protocols for each piece of equipment that cover common issues like sampling procedures and analytical methods.
4. Maintain thorough documentation of your cleaning validation studies, including the protocols, results, and final reports stating whether the cleaning process for each piece of equipment is valid.
5. Implement a continuous verification program for routine residue monitoring after initial cleaning validation.
6. Be prepared to demonstrate that your cleaning procedures can consistently clean equipment to predetermined standards using scientifically sound sampling and analytical test methods.
7. Have data available to support your rationale for residue limits, which should be logical, practical, achievable, and verifiable.
8. Be ready to explain your approach for different types of equipment (dedicated vs. multi-use) and how you handle potent compounds or other high-risk materials.
9. Review your cleaning agent selection process and be able to justify the cleaning methods and agents used.
10. Ensure you have a system in place for equipment maintenance and cleaning records.
11. Be prepared to discuss how you handle manual vs. automated cleaning processes and any associated validation differences.
12. Review past audits or inspections and ensure any previous findings related to cleaning validation have been addressed.

Let me know if I’ve missed anything.