شناسایی و تحلیل ریسک های کیفیتی محصول در صنعت دارویی (مطالعه موردی: شرکت داروسازی دانا)

نوع مقاله : مقاله پژوهشی

نویسندگان

1 پاستور جدید مابین طالقانی و مقصودیه ساختمان پردیس ط 3

2 مشاور سیستم های کیفیت IMS و ISO17025

چکیده

تولید داروﻫﺎی ﺑﺎ ﮐﯿﻔﯿﺖ ﭘﺎﯾﯿﻦ علاوه بر اتلاف منابع، منجر به ایجاد خطراتی برای سلامت عمومی می‌گردد. مدیریت ریسک کیفیتی با کنترل ریسک‌های کیفیتی در مراحل ساخت محصول، کیفیت بالای دارو را برای بیمار تضمین می‌نماید. پژوهش حاضر با اجرای این فرایند بر اساس راهنمایICH Q9 در شرکت داروسازی دانا، به شناسایی و تحلیل ریسک آلودگی ذره‌ای محصول ویال پرداخت. برای این منظور جهت شناسایی ریسک از تکنیک FMEA، برای یافتن علل ریشه‌ای خرابی از تکنیک Why RCA و جهت تحلیل ریسک تلفیقی از تکنیک‌های FMECA و BBN استفاده گردید. مقایسه نتایج دو رویکرد FMECA و BBN-FMECA نشان داد که در این شرکت، تحلیل ریسک با هر دو روش نتایج مشابهی به دست می‌دهد. رویکرد BBN-FMECA جزئیات بیشتری در مورد سطوح ریسک ارائه می‌دهد. همچنین کیفیت پودر ماده اولیه و مواد بسته‌بندی اولیه، عملکرد پرسنل و سیستم پایش هواساز، مهم‌ترین علل ریسک آلودگی محصول شناسایی شدند.
 

کلیدواژه‌ها

عنوان مقاله [English]

Identification and Analysis of Product Quality Risks in pharmaceutical industry (Case study: Daana Pharmaceutical Co.)

چکیده [English]

Abstract: The production of low quality drugs in addition to wasting resources, leads to risks to public health. Quality risk management can ensure the high quality of the drug for the patient by controlling quality risks during the product manufacturing process. The present study aimed to identify and analyze the particle contamination risk of the vial product at Daana Pharmaceutical Company by implementing quality risk management process based on the ICH Q9 guideline. For this purpose, in order to identify the risk, the failure modes and effects analysis (FMEA) method and to identify the root causes of failure, the "Why" root cause analysis (Why RCA) technique and to analyze the risk, a combination of the failure modes, effects and criticality analysis (FMECA) and Bayesian Belief Network (BBN) analysis methods were used. Comparison of the results of the FMECA and BBN-FMECA approaches showed that at Daana Company, risk analysis with both methods gives similar results. Also quality of raw material powder and primary packaging materials, personnel performance and air conditioning monitoring system are identified as the most important causes of product contamination risk

کلیدواژه‌ها [English]

  • Quality Risk Management(QRM)
  • Failure Modes and Effects and Criticality Analysis(FMECA)
  • Bayesian Belief Network(BBN)

مراجع

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نشریه علمی پژوهشی مهندسی و مدیریت کیفیت
دوره 11، شماره 3
آذر 1400
صفحه 261-284

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