Syner-G was contracted by a virtual U.S. Biopharma company to perform the responsibilities of their Quality Assurance function, locally in India. Syner-G Team was vested with responsibility (Quality and Compliance) of two CDMO sites in India for the manufacture of Drug Substance. The legacy contract continued after the takeover of the product portfolio by a Big Pharma.
- Ensured uninterrupted supply of compliant DS for the past 20 months (without any single rejection)
- Procedures were harmonised, procedure vs practise was streamlined.
- CDMO sites are kept inspection ready and there is an overall improvement in Quality Culture
QA resources (Person-in-Plant – 2 resources) were expected to ensure quality and compliance for drug substance in the Phase III clinical trial. Release of intermediate and DS batches, witnessing critical activities, tracking of QMS activities related to DS, periodic audits such as facility audits, surveillance audits, pre-inspection audits and support of Mock/QP/Supplier Qualification/ Regulatory audits were also part of the assignment. The assignment continued for commercial batches after the DP entered market.