Operational Quality Support

Operational Quality Support

In the Operational Quality area our consultants can support you by review of batch documentation, management of changes, management of deviations and management of Corrective and Preventive Actions (CAPA). Moreover, our consultants are able to advise and support you in process and cleaning validation. Finally, our consultants are able to setup or improve standard operating procedures and setup and implement a complete Quality Management System.

Currently, a large international pharmaceutical company (MSD Oss) is using our Operational Quality service at a sterile manufacturing plant.

Moreover, in an international setting, we prepared one of our customers (S&N) for an FDA audit. Our consultants were in the lead for an extensive back-log remediation program. Among others, a cleaning, a gowning, and a sterility testing program were setup. As a measure of success: The FDA had no observations on the remediated actions.

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