Compliance

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.