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Process Validation

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دلوقتي لو مستحضر كان بيتصنع في شركة و تم نقل تصنيعه لشركة تانيه و هيتعمله process validation 

ساعتها هتكون concurrent process validation ولا prospective process validation ؟

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Mohamed El-Khatteb
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ال concurrent بيكون لمستحضر انت بالفعل بتنتجه على المكن بتاعك انت وعندك تاريخ له عندك
لكن انت نقلت التصنيع على مصنع تانى ومكن تانى وناس تانية فبكل تاكيد ده prospective والصح يتعمل engineering batch او اكتر تستقر فيها عال parameters وبعدها تعمل phase 2 validation batches.
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Senior QA specialist
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Prospective as in WHO

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Mohamed Reda
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Prospective (check for WHO Annex 7 technical report, no961) 

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