decommissioning

Decommissioning

A GMP gap analysis evaluates whether your current facility meets cGMP requirements and is a great way to lower risk and bolster decision making for future revamp or optimization projects.

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.

Our team also have extensive expertise in the decontamination of all types of manufacturing, clinical trials, R&D and Bulk API facilities.

BG decommissioning

Core Capabilities within Decommissioning and Decontamination

Over the years, we have assisted many clients in the safe decommissioning and decontamination of facilities, and consequently, the services that The GAMP Group can offer within this area include Planning, Risk Assessments, Method Statements, and Tracking/Monitoring of Waste Disposal.

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