Advent Bioservices Ltd

 Brief:

GMPG were requested to carry out qualification of two aseptic manufacturing suites located at Advent Bioservices Ltd. in Cambridge, England. The suites had been built and handed over by the contractor.

What we did:

GMPG initially carried out an audit of the documentation available and procuded a GAP anaylsis report for missing or poor quality documents. GMPG then developed a Validation Plan (VP) for the facility's HVAC systems and environmental monitoring system.

GMPG also developed a full set of qualification documents in accordance with the VP, which included:

• Risk Assessments
• Design Qualification
• Trace Matrix
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• IQOQ Report

The cleanrooms were qualified to ISO 14644, including smoke visualisation testing. 

Result:

The aseptic suites were fully qualified in accordance with the VP. The client has since produced three validation batches of the product.