Risk-based approach to qualification and process validation

Beijing Fresenius Pharmaceutical needed an experienced partner to establish a new validated pharma production facility with European equipment. NNE did exactly that – and also stayed on site until production was running with full GMP compliance.

Beijing Fresenius Pharmaceutical planned to establish a mono-product facility in China. The company approached NNE looking for a new facility, including process validation up to the start of commercial production. NNE's solution was a turnkey facility and support with the complete qualification and process validation – from validation master plan up to the start of commercial production. Beijing Fresenius Pharmaceutical benefited from receiving a complete solution – which minimised the company’s risk and met all project requirements efficiently and successfully.

Risk-based approach and close teamwork

Because the manufacturing process for the product was quite complicated, NNE's validation experts needed to consider many different aspects of the product properties and the manufacturing process. An interdisciplinary, international team was assembled to work closely with the customer – so that local considerations and European equipment standards could be taken into account. NNE applied a risk-based approach to the qualification as well as to the process validation.

Being there from start to finish

After preparing all qualification phases and the process validation, the NNE team supervised and documented the results of the first batches produced in full production scale and stayed on site until the commercial production was running in full compliance with the GMP regulations. The team also supported the company in variation management for the regulatory dossiers.

Quick facts

Customer

Beijing Fresenius Pharmaceutical Co. Ltd.

Country

China

 

 

Project duration

Jan. 2002 – Mar. 2005

Services provided

In the context of delivering a turnkey production facility: qualification (from VMP up to OQ), support in variation management for the regulatory dossiers, process validation, support during authority inspection