Manufacturing Process Design and Control
To compliment the formulation development services, H2 Pharma provides specialised consultancy in manufacturing process design, control and technical problem-solving.
We provide practical solutions to process challenges and assist Clients with the construction, implementation and management of all aspects of the process development plan.
We adopt industrially-recognised risk-assessment tools and assist Clients with the utility of these tools throughout the product development life-cycle.
Our services include:
- Risk analysis of manufacturing processes (FMEA, Britest)
- Development of process plans and design of experiments
- Practical guidance on utility of “Quality-by-Design” principles
- Interpretation and application of ICH-Q8 and -Q9 guidances
- Development of Process Analytical Technology (PAT) strategies