Emergency and Evacuation Plan

This SOP outlines the procedure to follow in an emergency situation. It should include details of how to protect any manufacturing that is in process at the time of an evacuation.

Equipment Register

This register lists all the equipment in a facility including critical equipment.

Equipment Maintenance SOP

This procedure describes the system, provides instructions and identifies responsibilities for maintenance of key process equipment and the support systems

Environmental Monitoring Procedure

This document describes the environmental monitoring program for the clean areas of the manufacturing facility. It includes surveillance of temperature, relative humidity and air pressure, microbial contamination and particulate air matter.

Cleanroom Cleaning Procedure

The purpose of this SOP is to outline the procedures and materials used in the routine cleaning of cleanrooms and associated clean areas within the facility.

Organisation Document

Description of the organisation, the staff, management processes and organisation chart.

Site Master File

Identify all rooms, buildings, warehouses etc included in the Quality Management System.  May include a site map, organisation chart, an explanation of the people equipment and quality environment as well as a description of the activities that occur in each room of the facility.