This is a cleanroom Provision in a form consistent with the FDA QSR.
By clarifying the cleanroom management rules and Provision, we can standardize them within the company.
By standardizing the rules, we can smoothly respond to FDA inspections.
List of Forms
The following forms are included with your purchase.
・MD-QMS-K73 Clean Room Management Provision
Table of Contents
2 scope (of a document)
3 Definition of Terms
4 Clean room management
4.1 Cleanroom management supervisor or department responsible for management
4.2 Cleanroom Management Procedures
4.3 Daily inspection of clean rooms
4.4 Clean room cleaning
4.5 pest control
4.6 Environmental Monitoring
4.7 Management of equipment and devices in clean room
5 Personnel performing work in clean rooms
5.1 Worker qualifications and their control
5.2 hygiene management
6 Entering and exiting the clean room
6.1 Restricted access to clean rooms
6.2 Entry to clean room
6.3 Exit from clean room
7 Bringing in and out chemicals and other materials to and from the clean room
8 Prohibited items in clean rooms
9 Criteria for determining corrective and preventive action requests