Technology transfer (TT) is crucial for ensuring product consistency, compliance, and scalability in topical formulations (creams, gels, ointments). A structured TT minimizes risks in scale-up, process validation, and site transfers.
R&D to Manufacturing Transfer
- Define Critical Material Attributes (CMAs) & Critical Process Parameters (CPPs) (e.g., homogenization speed, shear rate).
- Process optimization for rheology, phase inversion, viscosity control.
- Scale-up & validation batches with comparative IVRT & stability studies.
- Documentation: TTD, BMR, risk assessment (FMEA), cleaning validation.
Site-to-Site Transfer
- Gap analysis: Equipment, raw material variability, water quality impact.
- Process & equipment equivalence: Adjust shear forces, mixing time, temperature profiles.
- Regulatory compliance: Change control, dossier updates (CTD, eCTD), GMP adherence.
Successful TT requires QbD-driven process control, cross-functional collaboration, and regulatory alignment to ensure smooth commercialization.
Read also:
- Phases of a Technology Transfer Project in Pharmaceutical Industry
- Major Documents for Technology Transfer in Pharma Industry
Resource Person: Rahul Bhawsar