The International Society for Pharmaceutical Engineering (ISPE) have released their latest guidance document, ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities. This guide provides an overview of best practices to be used for the decommissioning and disposal of assets ranging from a single item to a whole facility.
“The guide also brings together a wealth of information and sample documents that can significantly aid in the decommissioning process,” said Nick Haycocks, Senior Specialist QA, Amgen Inc. “It’s truly a one-stop-shop for information, featuring checklists, templates, and flowcharts currently used in the US and Europe,” added Mark Foss, Central Engineering and Facilities Director, UK Manufacturing, CooperVision.
The ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities describes a risk-based approach for planning and documenting the decommissioning process to meet the requirements of regulatory authorities. This guide also provides examples and sample documents for how this approach can be carried out in practice.
Key Concepts include:
- Guidance on decommissioning
- The use of a decommissioning determination process
- Planning for Good Engineering Practice (GEP) and GxP systems
The Good Practice Guide is a collection of the practical advice and experience from a wide range of personnel in the life sciences industry. The contributors of this guide have a great deal of experience through site closures, equipment decommissioning, and product/equipment transfers.
Get your copy the ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities.
