Boehringer Ingelheim

Brief:

 The client were carrying out major modifications to the purification suite as part of an animal vaccine process at their facility in Surrey, England.

GMPG were employed to carryout all CQV works for the project. The facility is a Category 3-4: Biocontainment Unit, and is subject to specified animal pathogen order (SAPO 4) HSG280.

What we did:

GMPG set up a fully managed site operation to develop and execute all CQV documentation for the purification project. This included the production of URS's for all the facilities, utilities and equipment.

Together with risk assessments and trace matrixes, GMPG were responsible for all FAT and SAT witnessing. As part of the project, GMPG wrote and executed all decommission protocols for equipment to be removed.

In addition, GMPG wrote and executed all DQ, IQ, OQ and PQ protocols and produced validation reports to sign off all facilities, utilities and equipment. 

Results:

The project was completed on time, to budget, and validation batches were produced in line with the clients change control requirements.