化工背景走生技產業的前景 - 生技

Design features and decisions that deliver a high degree of confidence that
manufactured lots will have the intended product quality and performance

‧Design to specifications (not setting specifications after the fact)

能讓整個工作流程都能被記錄與詳述，而不是在得到結果後的的敘述

‧Redundant (i.e., an additional layer of security –risk based) end product
testing (not testing to document quality)

多次的測試產品的品質，而不是只有看文件而以

‧An ability to describe and justify why proposed design features deliver
with confidence the intended quality (not awaiting test results to be
submitted in a post approval supplement)

有能力說明或是證明這樣的設計可以提升產品品質，而不是在結果出現後再補足

Quality by Design (QbD)

‧“Means that product and process performance characteristics are
scientifically designed to meet specific objectives, not merely
empirically derived from performance of test batches.”

以科學化的設計流程好讓產品達到預期中的品質，而不僅是從每次

累積的經驗而來

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所有技術上的努力都要由關心人類和其命運出發
為了讓人類心智的創造物有益而不是有害

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