قررت هيئة الغذاء والدواء تعليق تسجيل أحد المصانع الدوائية الأوروبية، عقب زيارة تفتيشية كشفت «تجاوزات حرجة» وأخرى أساسية في ممارسات التصنيع الدوائي الجيد (GMP).
وشملت المخالفات المرصودة جوانب متعلقة بالإجراءات التصنيعية ونظام الجودة الداخلي للمصنع، ما يمثّل تهديداً مباشراً على سلامة المنتجات النهائية المخصصة للتصدير؛ وبناءً على نتائج التقييم الفني، اتخذت الهيئة قرار التعليق الفوري كإجراء احترازي يهدف لمنع تسويق أي مستحضر يشكل خطراً على صحة المستهلك.
وعدت الهيئة خطوتها امتداداً للنهج الاستباقي الذي تتبعه في تفتيش المصانع الأجنبية المورّدة، إذ تُنفّذ الزيارات الميدانية وفقاً لمعايير رقابية دولية وتُراجع فيها منظومات التصنيع والجودة وسجلات التشغيل والتخزين والتوزيع.
وتواصلت عدد من الجهات الرقابية الأوروبية مع الهيئة للاطلاع على الملاحظات الفنية التي رصدتها على المصنع واتخاذ الإجراءات اللازمة؛ ويُعد التفاعل الدولي مؤشراً على تنامي الثقة في كفاءة الهيئة ومصداقية مخرجاتها الرقابية، ودورها الفاعل ضمن المنظومة التنظيمية العالمية لسلامة الدواء.
وأكدت الهيئة أن الرقابة على المصانع الخارجية تُعد ركيزة أساسية في منظومة عملها التنظيمية، وتمارسها باستقلالية تامة وبالاستناد إلى أدلة علمية وميدانية؛ مشددةً على أن حماية المستهلك تظل أولوية قصوى، وأنها لن تتردد في اتخاذ ما يلزم من إجراءات حازمة عند رصد أي خلل قد يؤثر على سلامة المستحضرات الصيدلانية.
السعودية: «تجاوزات حرجة» تعلّق تسجيل مصنع دواء أوروبي
15 يوليو 2025 - 05:09
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آخر تحديث 15 يوليو 2025 - 05:09
تابع قناة عكاظ على الواتساب
«عكاظ» (الرياض)
The Food and Drug Authority has decided to suspend the registration of one of the European pharmaceutical factories following an inspection visit that revealed "critical" and other essential violations in Good Manufacturing Practices (GMP).
The observed violations included aspects related to manufacturing procedures and the factory's internal quality system, which pose a direct threat to the safety of the final products intended for export. Based on the results of the technical assessment, the authority made the immediate suspension decision as a precautionary measure aimed at preventing the marketing of any product that poses a risk to consumer health.
The authority described its step as an extension of the proactive approach it follows in inspecting foreign supplying factories, as field visits are conducted according to international regulatory standards, reviewing manufacturing and quality systems as well as operational, storage, and distribution records.
Several European regulatory bodies have contacted the authority to review the technical observations noted about the factory and to take the necessary actions. The international interaction is an indicator of the growing confidence in the authority's efficiency and the credibility of its regulatory outputs, as well as its active role within the global regulatory framework for drug safety.
The authority confirmed that oversight of foreign factories is a fundamental pillar of its regulatory work system, conducted with complete independence and based on scientific and field evidence. It emphasized that consumer protection remains a top priority and that it will not hesitate to take necessary stringent measures upon detecting any issues that may affect the safety of pharmaceutical products.
The observed violations included aspects related to manufacturing procedures and the factory's internal quality system, which pose a direct threat to the safety of the final products intended for export. Based on the results of the technical assessment, the authority made the immediate suspension decision as a precautionary measure aimed at preventing the marketing of any product that poses a risk to consumer health.
The authority described its step as an extension of the proactive approach it follows in inspecting foreign supplying factories, as field visits are conducted according to international regulatory standards, reviewing manufacturing and quality systems as well as operational, storage, and distribution records.
Several European regulatory bodies have contacted the authority to review the technical observations noted about the factory and to take the necessary actions. The international interaction is an indicator of the growing confidence in the authority's efficiency and the credibility of its regulatory outputs, as well as its active role within the global regulatory framework for drug safety.
The authority confirmed that oversight of foreign factories is a fundamental pillar of its regulatory work system, conducted with complete independence and based on scientific and field evidence. It emphasized that consumer protection remains a top priority and that it will not hesitate to take necessary stringent measures upon detecting any issues that may affect the safety of pharmaceutical products.
