PIC/S：Guide to Good Manufacturing Practice for Medicinal Products （Part I、Annexes） PE009-17 (25 August 2023) © PIC/S 25 August 2023
製造許可的持有者製造藥品時，應確保該藥品適合其預定用途，符合上市許可或符合臨床試驗許可（合適時）的要求，且不會由於其安全性、品質或有效性的不足而使病人陷於危險。該品質目標之達成是高層管理者的責任，且需要公司內各部門及所有階層之人員，以及公司之供應商與經銷商的參與和許諾。為可靠達成該品質目標，應有全面設計並正確實施的製藥品質系統。該系統涵蓋優良製造規範及品質風險管理，應充分文件化，並監測其效果。製藥品質系統的所有部門應適當配置能勝任的人員，以及合適且足夠的廠房、設備與設施。製造許可的持有者及被授權人另有其他法律責任。
The holder of a Manufacturing Authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization or Clinical Trial Authorization, as appropriate, and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorization and for the Authorized Person(s).
品質管理、優良製造規範及品質風險管理的基本概念是相互關聯的。在本章予以描述，以強調其間之關係及其對於 藥品生產及管制之基本的重要性。
The basic concepts of Quality Management, Good Manufacturing Practice (GMP) and Quality Risk Management are inter-related. They are described here in order to emphasize their relationships and their fundamental importance to the production and control of medicinal products.
範圍 本附則之一般原則可以應用到無菌產品外的其他領域。
無菌產品之製造涵蓋廣泛的無菌產品類型（包括原料藥、賦形劑、直接包裝材料及成品劑型）、包裝規格（由單一到多單元包裝）、製程（從高度自動化系統到手工製程）及技術 （例如生物技術、傳統小分子製造系統及密閉系統）。本附則提供的一般指引應被用於設計及控制所有無菌產品製造的廠房設施、設備、系統及程序，並使用品質風險管理（QRM） 原則，確保最終產品不受到微生物、微粒及內毒素/熱原的污染。