When Abdi Ibrahim needed to quickly expand capacity and build a multiproduct, multipurpose facility that fulfilled all international standards, they looked for a collaboration partner that offered high-quality services with close links to European vendors. NNE proved to be the right fit, and from the beginning the two companies worked closely together for the CD, BD and DD to find the best design solutions and make the facility world-class.
Abdi Ibrahim is a Turkish pharmaceutical industry leader and has the largest product portfolio in the sector, exceeding 180 brands and 350 products. The new facility will be in Istanbul and will accommodate 14 different processes with a fast change over from one process to another. Each type of production will be segregated into floors and include the following:
- Conventional OSD production
- Sterile production
- BFS production
- Oncology production
In addition, all production units will have visitor access via a visitor corridor that looks directly into production suites to showcase Abdi Ibrahim’s capabilities to potential CMO customers.
Fast execution with a close, multi-cultural collaboration based on mutual respect
One major challenge of the project was that Abdi Ibrahim needed a high-quality, flexible facility that was built within a reasonable budget and executed fast. To do this, NNE utilised both their Danish workforce and their engineering hub in India while Abdi Ibrahim brought in their team from Turkey.
The close collaboration between engineers, architects, subject matter experts and users, as well as the high involvement of ABDI core management team in the early stage, was crucial to meeting the fast-track schedule and the project’s success. Despite the distance and different time-zones, they had daily meetings to exchange knowledge and developed strong relationships built on respect for each other’s competences. Indeed, the different time zones proved to be an advantage for the fast execution of the design, as each group could pick up where the other had left off.
Very good teamwork, great contribution, great collaboration – we were very satisfied with the project
An advanced, flexible, GMP compliant design with high levels of health and safety
Core focus areas for the design and the allocation of different production areas were process flexibility, logistics and flow, and GMP compliance. Furthermore, a stepwise expansion plan makes the design highly flexible and allows Abdi Ibrahim to expand their product portfolio and production capacity in the future.
To support lean manufacturing and fast track execution, the qualification strategy for the facility applies the ASTM E2500 verification approach. The goal is to move away from ‘paper quality’ and rigid documentation practices, with advantages such as:
- Faster project execution
- Focus on patient safety
- Significant reduction of documentation
- Enhanced process understanding
- Saved time and resources
- Higher production yield (OEE)
- Improved quality at lower costs with the better use of expertise
- Compliance with health authorities’ expectations to risk-based approach
Alongside this, advanced IT and automation systems will support the high level of quality and compliance, such as a laboratory information management system, a training management system, fully IT supported weighing and dispensing of materials for production and a central system for maintenance and calibration management.
The facility is planned to be approved worldwide by EU, FDA and SFDA in 2022.
Oral solid dosage, fill finish, medical devices
- Workshop format
- Workshops at customer site
- Work in DK and India between workshops
Conceptual design, basic design and detailed design review