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New Guidance For Pharmaceutical Companies

New Guidance For Pharmaceutical Companies

Wednesday 5th July 2017

Even when you are placing your next order for pneumatic valves you need to be aware that not all machinery will last forever, and one day you will need to decommission your equipment.

A best practice guide has been released by the International Society for Pharmaceutical Engineering (ISPE). It is called the ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities.

The International Society for Pharmaceutical Engineering (ISPE) is the world's largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. Its 18,000 members develop and manufactures pharmaceuticals.

Covering the decommissioning of single items through to entire plants, the best practice guide gives people in the industry a step by step guide on how to decommission any and all equipment.

It includes:

• Guidance on decommissioning
• The use of a decommissioning determination process
• Planning for Good Engineering Practice (GEP) and GxP systems

Also covering the disposal of pharmaceutical equipment this document looks at the risk associated with different systems. There are flow charts and diagrams showing how each process could work.

Of course each country works within its own regulatory framework and you will need to consider hoe these processes would translate to your own country, but there is a great framework for you to base your disposal processes on in future.

Find the newly released ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities at www.ISPE.org/Publications-Guidance-Documents.

Additional Resources

Fluid Compatibility Guide

Product Catalogues

Certification Library