Facility Sanitation Qualification
MFDA can assist you in developing a Qualification Protocol for
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:
Protocol Approval Page
Table of Contents
Purpose
Scope
Responsibilities
Facility Description
Equipment Description
References
Standard Operating Procedures
Instrument Calibration Review
Test Instruments
Facility Cleaning Procedures and Execution
Frequency of Cleaning & Testing
Sample Locations
Sampling Procedures
Microbiological Monitoring
Types of Testing to be Performed
Surface Bioburden Testing (RODAC Plates)
Airborne Testing (Air Sampler)
Acceptance Criteria for Testing
Acceptance Criteria Summary
Protocol Summary Report
Protocol Deviations and Corrective Actions
Protocol Document Requirements (Attachments)