臺灣PIC/S GMP 製藥現況與製程品質暨實例分享

The Applications to Pharmaceutical Plants of PIC/S in GMP and Quality of Manufacturing Sample in Taiwan

楊品誠(Pin-Cheng Yang)

《臺灣臨床藥學雜誌》 24卷4期 (2016/12) Pp. 300-307

https://doi.org/10.6168/FJCP.2016.2404.05

摘要

PIC/S (The Pharmaceutical Inspection Convention and Co-operation Scheme) 促進法規制度與各國藥品GMP (Good Manufacturing Practice) 官方稽查標準的一致化，並提供國際合作平臺。身為會員之一的臺灣期待在醫藥產業在製藥制度與工業上，與其他先進國家並駕齊驅。另外，因應各國市場開放，市場擴張以及藥品的數量增加，為有效管理，法規上的配合與國際合作也成為必然。因此，國際製藥品質的管控趨勢，為在各項管理如知識管理、風險管理、稽查管理等品質管理上的精益求精、國際市場上的法規調和，以及重視在製程設計上即顧及製藥品質的廠房設計理念。達成國際製程品質標準之友霖生技雲林廠，在建造規畫之初即實踐QbD (quality by design)理念，提供一個合理、安全、穩定的生產藥品場所，其中實踐於所有的設施、設備、公用系統，其中製水系統中，無論純水或注射用水皆屬於製藥原料之一部分，所以每一個設備每一個步驟都是品質的控管。空調系統綜合各類關鍵因素計算結果，使得藥品製造在保證品質情況下，不會造成交叉污染，對藥品及人員皆能獲得保障。整體友霖建廠設計原則，符合國際藥廠規範之趨勢，實為臺灣製藥廠的建置標竿。

關鍵字

PIC/S ； GMP ； 生技藥廠

並列摘要

PIC/S (Pharmaceutical Inspection Co-operation Scheme) provides an international platform to facilitate the regulation system of official GMP inspection applied to all member countries. As being one of the PIC/S members, Taiwan is looking forward to be competitive internationally in terms of the pharmaceutical industry and manufacturing quality. In the trend of global market expansion, the product quality control of manufactures more result from the efficient managements on international regulations coordination, inspection, knowledge management, and manufacturing management. For example, the Orient Pharma Yunlin plant in Taiwan, which conforms the international manufacturer standard, is designed in the very beginning and constructed not only for preventing cross-contamination to meet the standard of twenty years to come but also fulfilling the concept of QbD (Quality by Design). The QbD concept is applied to all facilities and systems including water system and Heating, Ventilation and Air Conditioning (HVAC) system. Both purified water and water for injection are parts of production materials, therefore each process and equipment is strictly monitored. HVAC system manages the calculation of the key factors to ensure the prevention of cross-contamination and the production quality as well as the safety of the crews. In general, the design principle of QbD plant is able to meet the international standard and trend and becomes the benchmark pharma manufacture in Taiwan.

並列關鍵字

PIC/S ； GMP ； Pharmaceutical Plant