Your Account |

Show all documents

Standard Operating Procedure

Checklists Master Plans

Pre-Approval-Inspection

GMP Guide

Standard Operation Procedure

FDA

Process Validation

Bookmark this site:

Preventive maintenance (PM) procedure
Standard Operating Procedure

New

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.

Download sample page



	Price:	79.– EUR * (appr. 102.- USD)

* additional 19% tax for customers from germany / no shipping costs will be charged



	Delivery item:
		Open Word Document* You will be able to enter your data into the Word document. Please note: We do not deliver hard copies.



	Further details of this Standard Operation Procedure: Table of Content of this Standard Operating Procedure: 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

Customers who bought this item also bought:

Change control system

Annual product review

Supplier certification program

Deviations (failure investigations, non-conformance)

Product Recall


	© GMP ONLINE CONSULTANCY - Impressum - Imprint

Preventive maintenance (PM) procedure Standard Operating Procedure

Preventive maintenance (PM) procedure
Standard Operating Procedure