Beijing Fresenius Pharmaceutical planned to establish a mono-product facility in China. The company approached NNE Pharmaplan looking for a new facility, including process validation up to the start of commercial production.

The solution was a turnkey facility and support with the complete qualification and process validation – from Validation Master Plan (VMP) 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, the NNE Pharmaplan 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 client – so that local considerations and European equipment standards could be taken into account.

NNE Pharmaplan 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 Pharmaplan 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.