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Register a new userImprovement of quality of medications through implementing the six sigma methodology
تحسين جودة الأدوية من خلال تطبيق منهجية ستة سيجما
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Innovation Journal ورقة بحثية
Publication date
2018
fields
Administration Science
and research's language is
English
Authors
د.باسل مخائيل العسس( باحث )
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د.باسل العسس
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إن المنافسة المتزايدة في سوق الأدوية العالمية وضرورة الوصول إلى مستويات أعلى من جودة المنتجات الصيدلانية تجبر الشركات المصنعة على البحث عن أساليب وتقنيات أكثر فعالية وموثوقية لإدارة الجودة واعتمادها والتي تسمح لهم بتقديم منتجات بأعلى مستوى جودة ممكن و خفض تكاليف الجودة مع الحفاظ على التوافق مع ممارسات التصنيع الجيدة الصيدلانية والمتطلبات الفنية والتشريعية. إحدى منهجيات إدارة الجودة الحديثة الشائعة هي Six Sigma، والتي أثبتت قدرتها العالية على زيادة أرباح الأعمال والقدرة التنافسية خلال أكثر من 30 عامًا من التنفيذ في قطاعي التصنيع والخدمات. وفي الآونة الأخيرة، تم اعتماد منهجية Six Sigma من قبل شركات الأدوية العالمية مثل باكستر، وإيلي ليلي، وجونسون آند جونسون، ونوفارتيس وحصلت على فوائد كبيرة من قدراتها. يهدف هذا البحث إلى دراسة إمكانية تحسين جودة الأدوية من خلال تطبيق منهجية ستة سيجما، ومعرفة الفوائد التي يمكن أن تحصل عليها شركة الأدوية من خلال تطبيق هذه المنهجية. تم إجراء دراسة حالة في إحدى شركات الأدوية في سوريا (أورينت فارما) بهدف دراسة فعالية ومزايا منهجية ستة سيجما. ولهذا الغرض، تم إجراء مشروع تحسين الجودة باستخدام خارطة طريق DMAIC لتحسين جودة أحد المنتجات الرئيسية للشركة. أظهرت النتائج التي تم الحصول عليها من مشروع DMAIC قدرة عملية معززة، ومستوى سيجما معزز للعملية، وانخفاض التباين في مخرجات العملية، ونتيجة لذلك تم تحسين جودة الدواء بشكل كافٍ. في الختام، يمكن الحصول على فوائد كبيرة من خلال تطبيق منهجية Six Sigma في صناعة الأدوية لتحسين جودة الأدوية وعمليات الإنتاج أيضًا.
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 techniques 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.
References used
D. V. Antipov, Yu. G. Gushyan, Yu. S. Klochkov, Yu. S. Eliseev, A. N. Chekmarev. Evaluation of the functioning of the system of logistics management of the quality of the technological process//Izvestiya Samarskogoauchnogo center of the Russian Academy of Sciences. 2016. Vol. 18. No. 4-1. P. 45-48.
K. B. Farris, D. M. Kirking (1993). Assessing the quality of pharmaceutical care II. Application of concepts of quality assessment from medical care//Annals of Pharmacotherapy, 27(2), 215-223.
I. H. T. Guideline (2005). Pharmaceutical development Q8.
I. H. T. Guideline (2008). Pharmaceutical quality system Q10.
I. H. T. Guideline (2005). Quality risk management Q9.
Y. S. Klochkov, A. D. Volgina, A. A. Karsuntseva, T. S. Selezneva, A. Yu. Gazizulina. Development of a product certification model based on QFD // Vector of the science of Togliatti State University. 2013. No. 4 (26). P. 111-113.
International Organization for Standardization (2015). Quality management systems — Fundamentals and vocabulary.
X. Y. Lawrence (2008). Pharmaceutical quality by design: product and process development, understanding, and control//Pharmaceutical research, 25 (4), 781-791.
T. Lofthouse (1999). The Taguchi loss function//Work Study, 48(6), 218- 223.
M. M. A. Potdar (2006). Pharmaceutical quality assurance. Pragati Books Pvt. Ltd.
A. Rostami-Hodjegan, P. R. Jackson, G. T. Tucker (1994). Sensitivity of indirect metrics for assessing «rate» in bioequivalence studies — moving the «goalposts» or changing the «game»//Journal of pharmaceutical sciences, 83(11), 1554-1557.
R. K. Roy (2010). A primer on the Taguchi method. Society of Manufacturing Engineers.
G. Taguchi (1986). Introduction to quality engineering: designing quality into products and processes (No. 658.562 T3).
G. Taguchi (1993). Methods for Evaluating Quality. ASME press.
G. Taguchi, S. Chowdhury, Y. Wu (2005). Taguchi's quality engineering handbook (Vol. 1736). Hoboken, NJ: John Wiley & Sons.
J. F. van Leeuwen, M. J. Nauta, D. De Kaste, Y. M. C. F. Odekerken- Rombouts, M. T. Oldenhof, M. J. Vredenbregt, D. M. Barends (2009). Risk analysis by FMEA as an element of analytical validation//Journal of pharmaceutical and biomedical analysis, 50(5), 1085-1087.
L. X. Yu, A. Raw, R. Lionberger, R. Rajagopalan, L. M. Lee, F. Holcombe, R. Adams (2007). US FDA question-based review for generic drugs: A new pharmaceutical quality assessment system//Journal of Generic Medicines, 4 (4), 239-246.
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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
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ires and expectations of customers and consumers, as well as to achieve profitability and continuity in the labor market in the long term. This study contributes to the efforts made by researchers to find effective ways and means that allow companies to measure and improve the effectiveness of their quality management systems, benefiting from the internal audit process of ISO 9001 quality systems, expanding the scope of audit to include audit of quality indicators and key performance indicators for the performance of the quality system as a whole, combined with the verification of compliance of the system with ISO 9001: 2015. The aim of the study is to improve the efficiency of the quality management system through internal audit of QMS.
This research is aimed at studying the matter of Six Sigma implementation in The Syrian Pharmaceutical Companies as a way to enhance the quality of drug products , and to determine the requirements for successful implementation Six Sigma , and what b
enefits and obstacles could be appear during the application process . This research has been executed as a case study by implementing Six Sigma Methodology at Orient Pharma. Company to realize the benefits and obstacles of the implementation . In addition to that , the existence of the determined requirements for successful implementation of Six Sigma in the studied company has been measured .And a theoretical study including many of important researches that studied this research's problem has been done , to review the results achieved and benefit of them in executing this study. Then , a simplified conceptual framework about Six Sigma concepts and methods has been formed. After that , the research studied the matter of implementing Six Sigma in Syrian Pharmaceutical Companies , and why they need it , and the fields that’s could benefit from Six Sigma . A group of (16) requirements has been determined as a "must to be" available before stating the application process , these requirements are divided into three main categories : Managerial requirements , Technical requirements , and Human requirements , which create together the suitable environment for successful implementation of Six Sigma.The most important results this research achieved are : it is applicable to use Six Sigma as valuable approach to enhance quality of drug products of the studied company, whereas significant improvements have been achieved through the DMAIC project such as increased quality of the drug product involved in it , decreased variability in the manufacturing process , and enhanced process capability to meet the desired quality requirements of the drug . In addition to that , a significant differences have been detected between the existed requirements in the studied company , and the needed requirements for the successful implementation of Six Sigma . The required role of the company top management , and the resistance of employees are the main obstacles for the successful implementation of Six Sigma in the company.Finally , some recommendations have been suggested to the company such as : the importance of the full existence of the determined requirements for successful implementation of Six Sigma before starting the deployment process , and the viable role of the consultant party that could qualify the employees and provide the needed training about Six Sigma concepts and methods , and to save and sustain the improvements achieved from the DMAIC project executed in the studied company .
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