On 15 June, ISPE announced the release of their latest publication, ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities. The Guide is intended to be a “one-stop-shop” for information to be used for decommissioning and disposal of assets ranging from a single system to an entire facility. The Guide takes readers through the decommissioning process, highlighting methods and systems that are based on industry practices developed in the US and Europe and that would meet regulatory requirements.

GxP Decommissioning Process Flow
GxP Decommissioning Process Flow

The basis of the Guide is to use a risk-based approach to manage and document the decommissioning process. Decommissioning determination, detailed in the Guide, provides focus to criticality and impact assessments, and enables significant reduction in the man hours that are used by directing resources and effort where it is needed most. The Guide provides best practices, industry examples, and templates to significantly aid in the optimizing the decommissioning process.

Key benefits of the Guide include:

  • Incorporation of a risk-based approach
  • Consideration of both regulatory and business needs
  • Definition of a structured process, including:
    • Common practices that apply to the preparation and to the decommissioning determination, which lead on to taking either the GxP (all areas of Good Practice, required by the relevant pharmaceutical regulations) route or GEP (Good Engineering Practice) route for decommissioning
    • Specific details for the GXP decommissioning process
    • Specific details for the GEP decommissioning process
  • Provision of examples and templates

View the table of contents for a complete overview of what you’ll take away from the ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities.

Get the Guide: ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

 

 

Thank you to all of the guide contributors:

Mark Foss (Co-Lead), CooperVision, United Kingdom * Daniel G. Franklin, CIRM, CxA, IPS, USA * Brett Gampper, Pfizer Global Engineering, USA * Nick Haycocks (Co-Lead) Amgen, Inc., USA * Diana K. Johnson, Elzinga Pharmaceutical Consulting Ltd., United Kingdom * Gary A. Knight, Commissioning Agents, Inc., USA * Raymond Loke, GMP Templates, Australia * Xavier Mol, Technord Automation, Belgium * Mark Andrew O’Donnell, Azzur Group LLC, USA * George S. Petroka, CIH, CSP, IES Engineers, USA * Andreas Schattschneider, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany * Frank van der Steen, FVCS, Netherlands * Steven J. Wisniewski, CAI Consulting, USA

RELATED POSTS