Interim Quality Assurance 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.