日本PDA製薬学会主催である技術教育委員会シンポジウム ～医薬品開発におけるDNA反応性（変異原性）不純物の管理～が2020年11月5日にオンラインで開催された。シンポジウムではICH M7に従った変異原性不純物の管理にフォーカスし，専門家によりオプション4の適用におけるパージファクターの計算方法や運用上の課題について発表された。また，シンポジウムでは，昨今医薬品の品質管理において大きなトピックとなっているニトロソアミン類のリスク評価についても重要なトピックとして取り上げられた。本論文ではシンポジウムにおける各演者の発表内容について要約する。

Continuous manufacturing is a manufacturing method in which raw materials are entered continuously in the manufacturing process throughout the duration of the process, and products are produced continuously through the manufacturing. Continuous manufacturing is applicable in various ways: Where all the stages of manufacturing process are continuous, from charging raw materials to discharging final products; and where only certain stages of the manufacturing process are continuous. With its continuous process operation, continuous manufacturing will be expected to maintain production efficiency irrespective of the equipment scale. By adjusting such as the continuous operating time in the process, continuous manufacturing can cater for a wide range of batch size. Therefore the same manufacturing equipment can be used from the developmental phase to the commercial phase. Continuous manufacturing is considered an efficient manufacturing technology, and considered to be one of major manufacturing technology in pharmaceutical production. Number of guidelines, however, published by regulatory agencies regarding continuous manufacturing is limited. There is no guideline by regulatory agencies specific to continuous manufacturing of biotechnological products. In this paper, we described points to consider when designing control strategy of continuous manufacturing of biotechnological products.