Quality Assurance

To ensure regulatory quality we offer qualified supervision of packaging activities of clinical study medication, including contract manufacturers, commencing from the study design (packaging design) to the release of the packed study medication. Duties we cover are e.g.

• Support of the managerial QA function for external international contract customers including monitoring and controlling of QA aspects and timelines
• Examination of batch record documentation (Master Batch Record, Batch Record)
• On-site presence at initial production of complex study medication in coordination with contract manufacturer
• Evaluation of deviation reports, preparation of trend reports
• Issuing of supply orders for identity tests on study medication
• Preparation of batch release for Qualified Person
• Review of release documents with regards to completeness and plausibility
• Archiving of GMP documents and filing of supporting documents in relevant IT systems
• Processing of quality complaints