Objective & context
To design and execute in a maximum of 3 years the Technology Transfer, from European Producer to North Africa Contract Manufacturer, of 6 multi dosages formulation products:
- 2 Coated Tablets
- 1 Hard Capsule
- 1 Vaginal Capsule
- 1 Cream
- 1 Oral Suspension
The Production Area assigned for this project was 2,400 sqm, already existing and partially equipped but not currently in use.
The difference in culture and working habits from a Multinational approach to a Local one was the biggest cultural issue that had to be solved.
The activity was divided in 3 phases:
Start Up of the Production Area
- Production Area Assessment to analyze the status of locals and equipment
- Feasibility study – Manufacturing & packaging tools and Batch Size definition
- Equipment – set-up, start-up and support to qualification activity
- Validation / registration strategy
- Validation Protocols and Batch Records writing support
- Materials estimation of needs
- Quality Control – analytical transfer and validation methods
- Trials batches execution
- Analytical tests
- Process Validation Reports – writing support
With people coming from both multinationals and from medium-sized companies, we had the capacity of putting into place a multicultural team of high level experts in the pharmaceutical field. We created a common work approach and environment which enabled employees to minimize their different professional habits (of personnel donors and receiving sites).