Preventive Maintenance

General

This SOP applies to work within GMP and Non-GMP areas were PM is scheduled. This includes work that is related to Environment Health & Safety regulatory requirements. This SOP applies to all associates responsible for making any type of Preventive Maintenance for instrumentations, equipments and utilities.

Regulatory basis, reference documents

• EU GMP Chapter 3
• 21 CFR 211.58

Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

3.1       Quality Management Representative / Quality Assurance

3.2       Engineering Head

3.3       Engineering Technician

4          Related documents

5          Definitions

6          Procedure

6.1       Preventive Maintenance Work Order

6.1.1    Execution of Work Order

6.1.2    Incomplete Preventive Maintenance

6.1.3    Non performed Preventive Maintenance

6.1.4    Preventive Maintenance Frequency

6.2       Trending

6.3       Archiving of PM Documentation

7          Attachments

7.1       Attachment 1: Management of preventive maintenance (1 page)

7.2       Attachment 2: Request for new preventative maintenance plan (1 page)

8          SOP distribution

9          Health, safety and environmental considerations

Size and Format:

    Microsoft Office 2003

    Word File

    11 pages procedure