- Procedures were harmonised, procedures vs practises were streamlined.
- Helped to reduce time to market by ensuring Quality is built into the process in the early phases of product development.
- Helped the CDMOs to improve overall Quality Culture thereby reducing Supplier risk.
Syner-G provided the QA resource (Person-in-Plant) to review and approve DS and DP in early phase development and Phase III clinical. The responsibility included review, assessment of impact and approval of mGMP documents generated for the Drug Substance and Drug Product by the Client and the related Vendor CDMO. QA resource must ensure phase appropriate GMP compliance and QMS activities related to the project have to be tracked. Support of QP/ Regulatory audits and Supplier Qualification audits are also expected.