Quality Assurance (QA)

Purpose

QA is responsible for the strategic and operational maintenance and development of the quality assurance area within GxP (Good x Practice) at Statens Serum Institute (SSI). QA ensures that requirements in permits issued by the Danish Medicines Agency (DKMA) to SSI for the importation and wholesale distribution of human and veterinary medicines are maintained. SSI also has permission from DKMA for the manufacture and import of pharmaceuticals and intermediate products for clinical trials and a DKMA permission for activities with veterinary autogenous vaccines. Here, QA ensures that requirements in the permits are maintained and that SSI departments and external contract manufacturers (CMO) involved in GxP activities are carried out in accordance with national/EU guidelines and legislation. The responsible manager in QA is also the Quality Manager for the ISO accredited laboratories at SSI.

Tasks

The following is an excerpt of the quality assurance tasks that fall within the department's responsibility:

• Secure construction and maintenance of SSI's overall GxP quality system (QMS) and ISO quality system (DS/EN ISO/IEC 17025:2017).
• Ensure that national and international GxP and ISO changes in legislation and guidelines are updated.
• Prepare and update overall QA QMS documents, as well as approval of overall ISO documents.
• Sparring for the GxP departments and ISO laboratories on quality tasks.
• Responsible for the release of commercial vaccines for both human and veterinary areas.
• Responsible for the release of unregistered vaccines and autovaccines to the veterinary field.
• Responsible for releasing the medicines manufactured at SSI, as well as API, active intermediates and cell banks for clinical trials.
• Responsible for the release of products produced by the CMO under SSI's responsibility.
• Responsible for GxP suppliers meeting the requirements through self-inspections, audits and quality agreements.
• Responsible for "quality oversight" at GLP studies, where SSI has delegated the GLP activity to a contract laboratory.
• Responsible for "quality oversight" for clinical studies where SSI is a sponsor or part of a partnership.
• Processing of complaints and recalls.
• Assessment and approval of documents at operational level.
• Holding the TLE (Top Management Evaluation) for the GxP and ISO areas.