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the Netherlands
Rated 4.55 of 5

Interim Quality Assurance consultancy

PCS helped Mallinckrodt (NL) get ready for a WDA inspection by providing interim QA consultancy.


Project summary

Interim QA consultancy with the goal of preparing Mallinckrodt for a regulatory GDP inspection.

Upgrading the GDP Quality Management System of Mallinckrodt (NL) to prepare them for an upcoming regulatory inspection. Including GDP training and interim QA consultancy.

PCS was requested by Mallinckrodt (NL) – now Curium – to perform a GDP gap assessment in anticipation of an upcoming regulatory inspection. PCS deployed two consultants to support the organization. Activities included GDP training, QA support and supply chain mapping. The QA department of Mallinckrodt was further strengthened as a result of the work, having more insight into the supply chain and related risks. In addition, some SOP’s were upgraded or clarified. The GDP inspection by the Dutch regulatory authority; IGJ, was passed with good result.

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