Good Practice Guide: Decommissioning Pharma Equipment & Facilities


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Published: June 2017
Pages: 132

Decommissioning is a general term for a process to remove something from active status. It may be a precursor to putting facilities/equipment into storage, repurposing, or demolition/disposal. There are many factors and requirements to consider in this process, including documentation, process management, Environmental, Health, and Safety (EHS) compliance, financial, operational, maintenance, supporting contracts, and interfaces with other facilities and site utilities.

The close-down of a pharmaceutical or medical device facility needs to be managed to ensure business continuity and GxP compliance up to, during, and post closure. This should be managed in a planned, controlled, and cost effective way that ensures a consistent supply of product for patients and positive outlook for employees.

The ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities provides information on best practices to be used for the decommissioning and disposal of assets ranging from a single item to a whole facility. This Guide brings together a wealth of information from a wide range of professionals in the Life Sciences industry, who have vast experience with site closures, decommissioning of small plant items through to complete operational sites, and product/equipment transfers. This Guide includes practical information from past lessons learned, helping readers to avoid re-inventing the wheel when it comes to decommissioning activities and supporting documentation.

The Guide aims to provide both definition and explanation of the process of decommissioning and is intended to be a “one-stop-shop” for basic information required for the decommissioning of equipment and facilities.

Decommissioning determination, detailed in this Guide, has brought a risk-based approach to the process and enabled significant reductions in the man hours that are used by focusing resources and effort where it is needed most. The ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities provides pharmaceutical industry examples, along with checklists, templates, flowcharts, and example documents, currently in use in decommissioning of pharmaceutical equipment and facilities in the USA and Europe. The Guide provides practical “how to” guidance for anyone engaged in decommissioning activities ranging from a single system to a whole site.