Geneka Group does not limit its activities to CMO but has set in the trend of Contract Research and Manufacturing Services (CRAMS) in the Indian Pharma industry. Geneka Group offers potential flexibility, quality, and economic advantages over batch processing, both in process development and manufacturing for the pharmaceutical sector. Over the past decade, We have been significant advancements in science and engineering to support the implementation of continuous pharmaceutical manufacturing. These investments, along with the adoption of the QbD paradigm for pharmaceutical development and the advancement of PAT for designing, analyzing, and controlling manufacturing, have progressed the scientific and regulatory readiness for continuous manufacturing. Building on this progress, we continue in several key areas to address the remaining implementation challenges.
We focus on 4 key points and that are :
- Product quality and performance are ensured through the design of effective and efficient manufacturing processes.
- Product and process specifications are based on a mechanistic understanding of how formulation and process factors affect product performance.
- Continuous real-time quality is ensured.
- Relevant regulatory policies and procedures are tailored to accommodate the most current level of scientific knowledge.
- Risk-based regulatory approaches recognize the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance and the capability of process control strategies to prevent or mitigate the risk of producing a poor quality product