Facility Sanitation that will qualify the use of germicidal agents
used to clean your GMP facility. This protocol will be tailored to
your specific cleaning process and germicidal agents used in your
facility.
The contents of a typical procedure may include, among others,
the following sections:
1. Protocol Approval Page
2. Table of Contents
3. Purpose
4. Scope
5. Responsibilities
6. Facility Description
7. Equipment Description
8. References
9. Standard Operating Procedures
10. Instrument Calibration Review
a. Test Instruments
11. Facility Cleaning Procedures and Execution
a. Frequency of Cleaning & Testing
b. Sample Locations
c. Sampling Procedures
12. Microbiological Monitoring
a. Types of Testing to be Performed
i. Surface Bioburden Testing (RODAC Plates)
ii. Airborne Testing (Air Sampler)
b. Acceptance Criteria for Testing
13. Acceptance Criteria Summary
14. Protocol Summary Report
15. Protocol Deviations and Corrective Actions
16. Protocol Document Requirements (Attachments)
