Fisher Scientific (formerly Patheon)

Brief: 

Fisher were introducing a new process for Liposome Injectable Suspension into their exisiting facility in Swindon, England. The 200l manufacturing process was skid mounted and prefabrecated in the USA, then delivered to and reassembled in the UK. GMPG were employed to carry out all commissioning, qualification and validation (CQV) activities.

What we did:

GMPG set up a full site team for the complete CQV project, alongside a Validation Master Plan, with sub-validation plans for:

• Facilities utilies
• Manufacturing equipment
• Automation and computer systems
• Manufacturing process
• Cleaning and analytical methods

The 200l project was fully resourced and managed by GMPG, whilst simultaneously undertaking the cleaning validation of a smaller scale, 45l project. 

Results:

GMPG took the project to client sign off on both 200l and 45l projects. The 45l project went to full production, whilst the 200l went to scale up trials.