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Process Validation

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Mohamed Saad

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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Senior QA specialist
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Prospective as in WHO

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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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Mohamed Reda
Best Answer

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

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