The quality of products in general is of great importance in the current time, and its impact on various aspects of life, such as economy, health and welfare of society as a whole is crucial and visible. It is vital to have a deep understanding of th
e product realization process, including understanding the dynamics under which the product quality changes
under the manufacturing conditions and the customer’s
(sensitivity) ability to recognize changes in product quality.
This article aims to develop and modify the Taguchi model
to suit the case of pharmaceutical products. The model of
pharmaceutical quality loss suggested in this paper can be
considered as a combination of the traditional concept of
quality model and the Taguchi model, modified to suit the
case of the pharmaceutical quality. The suggested quality
model can be used to assess quantitatively the quality
loss value that is associated with each deviation from the established tolerance zone; and accordingly to enhance the understanding of the pharmaceutical manufacturing process to avoid and prevent the occurrence of such loses of the pharmaceutical quality in the future.
The increased competition in the global pharmaceutical market and the necessity to reach higher levels of quality of the pharmaceutical products force the manufacturers to seek and adopt more effective and reliable quality management methods and tech
niques which allow them to introduce products with the highest possible quality level and reduced quality costs while maintaining conformance to the pharmaceutical GMPs, technical and legislative requirements. One of the popular modern quality management methodologies is Six Sigma, which proved its high ability to increase business profits and competitiveness within more than 30 years of implementation in manufacturing and service sectors. Recently, Six Sigma methodology has been adopted by global pharmaceutical companies such as Baxter, Eli Lilly, Johnson & Johnson and Novartis and obtained considerable benefits from its abilities. This research aims at investigating the possibility to improve the quality of medications through implementing the six sigma methodology, and to find out what benefits a pharmaceutical company can get through the implementation of this methodology. A case study was conducted in a pharmaceutical company in Syria (Orient-Pharma) in order to examine the effectiveness and advantages of Six Sigma methodology. For this purpose, a quality improvement project was conducted using DMAIC roadmap to enhance the quality for one of the main products of the company. The obtained results of DMAIC project showed an enhanced process capability, an enhanced process Sigma level, decreased variability in the process outputs, as a result the quality of the medication had been enhanced sufficiently. As a conclusion, considerable benefits can be obtained through implementing Six Sigma methodology in the pharmaceutical industry to improve the medications quality and the production processes as well.
