دراسة أثر تطبيق المواصفة 9001:2015 ISO في المعامل الدوائية بالاعتماد على مؤشرات الأداء الرئيسية: دراسة حالة معمل برولاين لصناعة الأدوية

الموضوعات

إدارة

روابط وملفات

التعريف والنوع

رقم الوثيقة

0859ea3d-2d3a-4350-a041-09d8fbc4a308

رقم العقد

0

نوع الوسائط

Crawler

نوع المحتوى

الرسائل العلمية

صيغة المصدر

رسائل ماجيستير

نوع الملف

pdf image

أسماء الملفات

0859ea3d-2d3a-4350-a041-09d8fbc4a308_1.pdf

بيانات النشر

ترجمة العنوان

Study of the Impact of Applying the ISO 9001:2015 Standard in Pharmaceutical Laboratories Based on Key Performance Indicators: Case Study Proline Pharma)

ألقاب المؤلفين

[{"name_ar":"تميم عليا ","title_ar":"اشراف","title_en":"Supervision"},{"name_ar":"فردوس محمد فتحي الحمصي","title_ar":"اعداد","title_en":"Preparation"}]

اللغة

Arabic

المصدر والدورية

اسم المصدر

دراسة أثر تطبيق المواصفة 9001:2015 ISO في المعامل الدوائية بالاعتماد على مؤشرات الأداء الرئيسية: دراسة حالة معمل برولاين لصناعة الأدوية

المحتوى والصفحات

عدد الصفحات

0

ترجمة الملخص

In this research, we will uncover the pivotal role that the effective implementing of quality management system (ISO 9001:2015) plays in ensuring the quality, effectiveness and safety of pharmaceutical products. We reveal the impact of adherence to these standards on key performance indicators (KPIs) in pharmaceutical laboratories. The significance of this research lies in illumination the benefit that can be obtained by commitment to ISO 9001:2015 standards in pharmaceutical companies, including providing a general framework of quality management system, risk assessment, and laboratory testing. Which demonstrate the commitment of the pharma companies to quality, safety, and efficacy, which is essential in a field where the stakes are lifesaving. The research also indicates the importance of measuring performance through performance measurement indicators to achieve efficiency and effectiveness in various operations. Utilizing a descriptive research methodology, the study draws from academic literature and field research conducted at Proline Pharmaceutical Manufacturing Plant. Data was collected through a checklist tool and analyzed. The main results reveal improved process efficiency, reduced waste, improved product quality and reliability, reduced operational costs, increased productivity and customer satisfaction, alongside reductions in errors and non-conformities. The research concludes with recommendations to adopt comprehensive quality management systems by commitment to ISO 9001:2015 standards and establish key performance indicators for ISO 9001:2015 requirements with regularly evaluate their compliance. These steps are essential for fostering a culture of quality and ensuring consistent product safety, which is crucial in an industry where precision, safety and compliance with standards and requirements are essential and non-negotiable.

إشراف وإعداد

الإشراف

تميم عليا

الإعداد

فردوس محمد فتحي الحمصي

الاقتباسات الببليوغرافية