【FDA CFR 820 QSR Compliance】Working Environment Management Procedure

¥200

【FDA CFR 820 QSR Compliance】Working Environment Management Procedure

【FDA CFR 820 QSR Compliance】Working Environment Management Procedure

¥200

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This is a formatted working environment control procedure in accordance with the FDA QSR.

List of Forms
The following forms are included with your purchase.
・MD-QMS-S703 Working Environment Management Procedure


 

Table of Contents

Procedure

1 Purpose
2 Scope
3 Definition of Terms
4 Roles and Responsibilities
5 Working Environment Management Procedures
5.1 Operational Preparation
5.2 Maintaining the work environment
5.2.1 cleaning
5.2.2 Temperature and humidity measurement
5.2.3 ventilation
5.2.4 Lighting Management
5.2.5 Tap Water Management
5.2.6 Working Environment Measurement
5.3 pest control
5.4 Anti-static measures
5.5 Dust-proof room management
5.6 Management of Area B and C areas
5.7 Establishment of restricted areas for the use of spray and spray insecticides
5.8 Setting up smoking and eating areas
5.9 Admission of outside visitors
5.1 Measures to be taken in the event of abnormalities in environmental facilities
5.11 Record keeping
6 reference
7 APPENDICES