藥品外包裝優質 管理系統 參考 案例 PIC / S GMP 主辦 機構 承辦 機構 協辦 機構 香港模具及產品科技協會 Hong Kong Mould and Product Technology Association PDA 香港醫藥經銷業協會 The Pharmaceutical Distribution Association of Hong Kong 香港生物科技研究院有限公司 The Hong Kong Institute of Biotechnology Ltd. 資助 機構 工業貿易署 此項目由 PDAHK 主辦,並由香港特別行政區政府 工業貿易署「中小企業發展支援基金」撥款資助 在此項目上 / 活動內(或項目小組成員)表達的任何意見、研究成果、結論或建議,並不代表香港特別行政區政府、工業貿易署或中小企業發展支 援基金及發展品牌、升級轉型及拓展內銷市場的專項基金機會(機構支援計劃)評審委員會的觀點。 PIC / S GMP
TXT_3.inddPDA
The Pharmaceutical Distribution Association of Hong Kong
/
PIC/S GMP
78
2015
7
8
2.15
IN THIS AREA
10
3.1
3.2
HEPA
5S
3. SEISO
5. SHITSUKE
4. SEIKETSU
18
3.18
Verifies that a process / piece of equipment performs as it is
intended to in the manufacturing process and produces product (in
process or final) meeting predetermined specifications.
A process designed to supply the documented evidence that a piece
of equipment operates as it is intended through all anticipated
operational ranges.
A process used to document that the piece of equipment was supplied
and installed properly and that appropriate utilities, i.e.,
electrical, steam, gas, etc. are available to operate the equipment
according to the manufacturers specifications.
Installation Qualification (IQ)
Operational Qualification (OQ)