It is essential that a cleaning validation protocol contains the necessary components to appropriately challenge a cleaning process. The purpose and design of a protocol is to identify the critical points of the system and to test those critical points by verifying that results consistently meet predetermined specifications. This outline is divided into sections with component descriptions which are found in most protocols.
Use this outline to assist you in developing your own protocol format.
- Scope and objectives
- Assign responsibilities
- Equipment and associated cleaning SOPs
- Cleaning Equipment Operational Status
- Cleaning validation methods
- Sample locations
- Sample and analytical test procedures
- Acceptance criteria
- Equipment and sample floor diagrams
- Monitoring worksheets