Скачать или смотреть Preventive Maintenance (PM) Procedure - GMP SOP - Standard Operation Procedure

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Description

The preventive maintenance program was and still is a focal point of GMP inspection. Agencies have realised that the preventive maintenance program is a crucial component of any modern quality system because it ensures efficient GMP operations.

The purpose of this Standard Operating Procedure (SOP) is to describe the procedures involved in commissioning, conducting and managing a site's preventive maintenance (PM) activities. This Standard Operating Procedure (SOP) applies to work within GMP and non-GMP areas where PM is scheduled. This includes work that is related to environment health & safety regulatory requirements. This Standard Operating Procedure (SOP) also applies to all employees responsible for any type of preventive maintenance for instrumentation, equipment and utilities.

It needs only a small amount of site-specific modification before it can be adopted to ensure an effective preventive maintenance program. The SOP can be used in the area of drug, drug substance, medical device and biotech manufacturing and contains 8 pages, including 2 attachments.

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Engineering head or designee
4.2 Engineering Technician or designee
4.3 Quality Assurance
5. Procedure
5.1 Generate Preventive maintenance work order
5.1.1 Execute Preventive maintenance work order
5.1.2 Incomplete Work Orders
5.1.3 Failure to execute Preventive maintenance to scheduled date
5.1.4 Preventive maintenance frequency changes
5.2 Trending
5.3 Archiving of PM Documentation
6. Distribution
7. Attachments
Attachment 1: Management of Preventive maintenance
Attachment 2: Request for new Preventive maintenance plan