AGM-Quality by Design
- To provide inputs for designing QbD based experimentation strategy for formula and process optimization,
- data modeling and data analysis with Design Expert by Stat-Ease and JMP, interpretation of results and provide way forward.
- Establishment of scale correlation principles from laboratory scale to pilot scale and their implementation during drug product development
- Evaluation of process analytical technology tools in product development
- To guide review of various QbD elements and to provide inputs/recommendations for risk mitigation plans
- Review of product development report from QbD perspective
- Provide scientific insight on the regulatory queries and to provide support to regulatory affairs department
- for timely response and approval.
- Provide training to supervise Associate Scientists/Research Associates/Trainees with respect to QbD principles and their implementation in product developments.
- Establishment of systems and SOPs for creating harmonized practices