QA is responsible for in-house GMP training and the administration of the Standard Operation Procedures (SOPs).
QA is responsible for planning and performing internal and external audits and issuing audit reports. The purpose of the audits is to make a survey of how the activities are carried out according to GMP, internal regulations, and customer/authority requirements. The audits secure that any divergence from the regulations will lead to implementation of necessary improvements.
The Qualified Persons (QPs) must be approved by NoMA and have the final responsibility for approval/release or rejection of API and Metformin granulate. Batch records are reviewed and controlled by the Quality Unit before release of each batch.
Vistin Pharma AS currently has 5 Qualified Persons (incl. trainees).
Detailed description of individual and department responsibilities are maintained in written job descriptions and responsibility matrixes.
Vistin Pharma AS has a separate Quality Unit (Q), divided in QA Assurance (QA) and Quality Control (QC) functions professionally independent of production, reporting directly to the Chief Executive Officer (CEO) as well as Regulatory Affairs (RA). The responsible person for the Quality activities is the Vice President Quality and Regulatory Affairs. The main responsibility of QA is to establish and maintain all systems necessary according to GMP and other relevant quality standards (GDP). An important instrument in monitoring quality is the Quality Management Review (QMR).