مراجعة شاملة لممارسات التوثيق في صناعة الأدوية
DOI:
https://doi.org/10.35516/jjps.v17i4.1405الكلمات المفتاحية:
التوثيق، بروتوكولات التحقق، إجراءات التشغيل القياسية، إدارة الغذاء والدواء، صناعة الأدويةالملخص
تسلط هذه المراجعة الضوء على الدور الحاسم للتوثيق في صناعة الأدوية، وهي صناعة تتطلب التحكم في الجودة والامتثال للوائح بشكل دقيق. يشكل التوثيق، بدءًا من إجراءات التشغيل القياسية وصولًا إلى بروتوكولات التحقق، أساس أنظمة ضمان الجودة من خلال تشكيل وتحسين عمليات التصنيع. نستعرض أهميته في الحفاظ على جودة المنتج وسلامة المرضى وتلبية المتطلبات التنظيمية، خاصة في عمليات التفتيش من قبل إدارة الغذاء والدواء الأمريكية والوكالة الأوروبية للأدوية. بالإضافة إلى ذلك، نستعرض التحول الرقمي في ممارسات التوثيق، بما في ذلك تقديم السجلات الإلكترونية للدفعات والتحديات والفرص المرتبطة بها. يؤكد البحث على ضرورة التوثيق المتين والدقيق وفي الوقت المناسب، مشددًا على أنه التزام بجودة المنتج وسلامة المرضى والصحة العامة.
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التنزيلات
منشور
كيفية الاقتباس
إصدار
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