Pharmaceutical Engineering in Turkey
Qualification and Validation Alla Turca
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.