Pharmaceutical Technology Transfer (Product and Process Engineering)

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.

Solution

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

Preparatory phase

• Validation / registration strategy
• Validation Protocols and Batch Records writing support
• Materials estimation of needs

Operational Phase

• Quality Control – analytical transfer and validation methods
• Trials batches execution
• Analytical tests
• Process Validation Reports – writing support

Added value

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).