國際無菌藥品GMP修訂趨勢及國內無菌製劑廠符合現況之研析   全文下載

Analysis on the Revision Trend of International Sterile Medical Products GMP and the Current Situation of Domestic Sterile Pharmaceutical Manufacturers

無菌藥品對於患者的用藥安全極具風險，因此除了一般的西藥藥品優良製造規範（Good Manufacturing Practice, GMP）要求以外，國際間對於無菌藥品的製造有更多額外規範，我國現行使用國際醫藥品稽查協約組織（Pharmaceutical Inspection Convention and Co-operation Scheme，PIC／S）GMP稽查標準的附則1即是針對無菌藥品的要求，2017年PIC／S組織公告修訂草案，內容已全面性修正，將對國內無菌製劑廠帶來衝擊；本研究透過問卷調查與實地診斷，探討新版法規上路時，業者可能遇到的問題，作為未來擬定業者輔導與訓練配套措施之參考，以期提升製藥水準，確保民眾用藥安全。

Sterile medical products are high risk to patients' safety. There are more good manufacturing practice (GMP) requirements for sterile medicine manufacturing compared to non-sterile medicinal products. In terms of GMP Guide for medical products published by the Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S), Annex 1 provides details for sterile products manufacturing. It is also the GMP standard used in Taiwan. In 2017, PIC/S has published a revised draft of Annex 1 for public consultation. There were significant changes in Annex 1, which would brought a great impact to the industry. Thus, through questionnaire and on-site analysis, this study explored the problems that manufactures may encounter. The results would be a useful information for the regulatory authority to prioritize the consultancy and resources to help the industry adapt to the new GMP requirements.