“Technology Transfer: A Key Pillar in Pharmaceutical Manufacturing”
Role of the Technology Transfer Department in the Pharmaceutical Industry
The Technology Transfer (TT) department is essential in moving pharmaceutical products from development to full-scale manufacturing. Their primary role is to ensure a seamless transfer of manufacturing processes, analytical methods, and technical knowledge from R&D to production, ensuring the product maintains its quality and compliance at a commercial scale.
Key Responsibilities:
- Knowledge Transfer: Ensures smooth handover of process knowledge and critical parameters from R&D to manufacturing.
- Process Validation: Validates and optimizes manufacturing processes for large-scale production.
- Regulatory Compliance: Ensures transferred processes adhere to global regulatory standards, including GMP.
- Risk Management: Identifies and mitigates potential risks during the transfer.
- Cross-Department Collaboration: Works closely with R&D, QC, QA, and regulatory teams to ensure alignment.
- Troubleshooting: Provides technical support and continuous improvement post-transfer.
- Scale-Up Support: Ensures processes developed at a small scale can be successfully scaled up.
- Documentation: Maintains detailed records of all transferred processes and knowledge.
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