Pharmaceutical Engineering in Turkey Qualification and Validation Alla Turca

Author / Editor: Dr. Peter Schober and Andrija Marinkovic / Dominik Stephan

Turkey is expected to be Europe's next–door emerging market: With its unique position between orient and occident and its focus on progress the country is set for growth. Projects in Turkey's emerging pharmaceutical industry offer great chances but also distinctive challenges – Chemgineering provided qualification and validation support for a Turkish pharmaceutical company in building a new plant for contract manufacturing. Read what two participants from Business and Technology Design experienced there.

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Turkey – The country between the two seas has linked the orient and occident for centuries and has rich natural and industrial resources.
Turkey – The country between the two seas has linked the orient and occident for centuries and has rich natural and industrial resources.
(Picture: Wikimedia Commons)

In the past few years, countries in south eastern Europe have made economic and industrial progress, especially Turkey. The country between the two seas has linked the orient and occident for centuries and has rich natural and industrial resources. Due to its strong and modern industry, the state is attracting more and more investors and manufacturers. Pharmaceutical production has played a major role in the general industrialization for quite some time. In the past two years, there have been several green field investments in this area in Turkey, each valued at over 50 million Euros.

The Desert Lives

Chemgineering was awarded to accomplish design reviews in the newly constructed plant of a pharmaceutical manufacturer, to qualify the HVAC facilities and to validate the computerized systems (CSV). The client's production site is located in central Turkey, far away from the port cities like Istanbul, Izmir or Antalya.

Gallery

As the perfect host, our client organized an exclusive hotel accommodation and the efficient transport from the hotel to the construction site with small mini-vans. The construction site was located in an industrial zone comprised of several thousand hectares which went to the horizon and seemed endless. Supposedly, this land was still a desert without asphalt and traffic just a decade ago. Also the relatively new highway, streets and buildings could be developed on it. Clearly large amounts were invested here and certainly others are planned.

There Must be Quality

Design reviews and qualification could be performed without interference. The design model was on a high level and required a lot of care and experience. We communicated in English, which the employees on the client side spoke rather well. Their written English was even much better than verbal expression, which was very important for creation of the documents . The client employees were nice and very extroverted in terms of the collaboration and about learning new things, particularly in the area of qualification, a relatively new topic in Turkey.

The client tried to procure as much as possible of the equipment from domestic manufacturers but not at the cost of quality. For example, air handling units from local manufacturers were installed. They were manufactured with the high quality as it is required in the pharmaceutical industry. Equipment components such as HPW plants or blister machines which are not produced in Turkey in the needed quality were from EU manufacturer ordered and installed. This means that our client was able to combine domestic and foreign products of the highest quality for this project respecting the local authorities , the EU laws and the GMP guidelines

Corporate Management with SAP

The construction of a new production facility also required the redesign of the company processes and thereby also the company software which should be used to control these processes. Chemgineering was entrusted with assisting in the validation of the SAP system. This task included validation coaching, validation planning and document review according to GAMP 5.

For handling the finance and controlling tasks the SAP module FI/CO was used which the company had been taken over from the parent company. The topic of computer validation was essentially new territory for the departments involved. At a joint on-site workshop at the Istanbul headquarters, the validation strategy was set with the most important milestones and the tasks were prioritized. There was already some preliminary work with the local implementation partners based on the standard SAP introduction method ASAP (accelerated SAP). However, it was quickly clear that the procedure needed to be more focused on the process. This required a lot of explanation and persuasion. But this was the only opportunity to get a grip on this complex project and to keep the test and documentation costs in hand based on risk.

Validating with a High Level of Motivation

The goal was, based on system-oriented specifications (business blueprints - BBP's), to divide the business processes within the planned SAP modules into main and sub-processes in a practical manner and to develop the respective validation documentation according to GAMP5. A universal multi-level risk assessment provided information on the test scope and depth.

The Chemgineering expertise from comparable projects was extremely beneficial. The time-consuming document creation process was supported by new client employees who were prepared in Istanbul for their future duties in the plant in central Turkey. As consultants, we were very impressed by the high level of motivation and the ability to grasp new information quickly as shown by these young college graduates.

Soft Skills Demanded

All project members spoke somewhat fluent English. At the same time, the communication turned out to be one of the greatest challenges. A SAP validation is per se no trivial matter and it is not always easy to express special issues and contexts in a foreign language in a direct and understandable manner. In addition, for the purpose of a review, relevant documents had to be translated into English or Turkish. Most of all in e-mail communication this requires patience from both sides. While the project was underway for well over a year, there were status meetings every two to three months in Istanbul to clarify unanswered questions personally, something which was essential despite all modern communication technology.

A decisive factor for the tasks as a consultant was a healthy portion of human empathy. That is because there were situations which made it necessary to respond to a sense of insecureness at some stages, to communicate between departments or simply to motivate people.

Due to the high level of commitment of everyone involved, the validation could ultimately be successfully concluded and the SAP system can begin operation with the official go-live.

Ready for New Projects

Our client as well as other pharmaceutical companies are planning the expansion of existing plants and building new ones. Thus, various new investments are to be expected in Turkey in the near future. Due to the positive experiences of the Business and Technology Designers, Chemgineering is looking forward to new projects in Turkey.

* The authors work as Senior Consultant and Project Engineer (respectively) for Chemgineering

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