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the Netherlands
Rated 4.55 of 5

Interim Quality Assurance consultancy

PCS helped Panacea Biotec gain WHO GMP compliance following a WHO inspection.


Project summary

Interim corporate QA consultancy with the goal of bringing Panacea Biotec in line with the WHO GMP requirements.

Following a WHO inspection, the GMP level of Panacea Biotec required an upgrade. PCS was retained to assist with the upgrade of Panacea's quality system and overall GMP awareness through interim corporate Quality Assurance support.

PCS initially deployed a team of consultants to assist Panacea in upgrading their GMP compliance level. A gap assessment against the WHO GMP requirements was performed. This resulted in an action plan to be implemented at a corporate QA level.

The action plan was subsequently picked up by Panacea and PCS consultants. The main focus of the plan was to restructure the quality management system, including the workflows where the corporate quality organization was participating.

The project lasted for approximately four years in which the quality management system of Panacea was restructured to meet the WHO’s requirements. The subsequent WHO GMP inspections were passed with good result.

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