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題名 | 中藥廠品管作業實務訓練=Practical Training in Quality Control for Chinese Medicine Manufacturers |
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作者姓名(中文) | 陳甘霖; | 書刊名 | 中醫藥年報 |
卷期 | 光碟版1:9 2012.10[民101.10] |
頁次 | 頁683-707 |
專輯 | 中醫藥產業實務規範 |
分類號 | 418.61 |
關鍵詞 | 中藥重金屬; 黃麴毒素; 微生物; 農藥殘留; Heavy metals; Microorganisms; Pesticide residues; Aflatoxin; |
語文 | 中文(Chinese) |
中文摘要 | “中藥廠品管作業實務訓練”課程,係與中醫藥委員會、 TFDA及業者討論後所決定課程講師及主題 (「有關中藥重金屬、微生物、農藥殘留及黃麴毒素之檢驗方法建立及注意事項」)。分實務接續課程(Ⅰ)及實務接續課程(Ⅱ) 2主題共舉辦 4場。實務接續課程()於高雄及臺中開課。內容為:一、中藥重金屬檢驗方法建立及應注意事項 二、中藥微生物檢驗方法建立及應注意事項 三、中藥農藥殘留檢驗方法建立及應注意事項 四、中藥黃麴毒素檢驗方法建立及應注意事項 五、污穢物質管制說明與實驗室管理 六、委外檢驗品管及品保經驗分享實務接續課程(Ⅱ) 於臺南及臺北開課。內容為:一、中藥廠的管理與因應經驗分享二、中藥品質管理常見問題分享三、GMP查廠時有關異常物質品管相關注意事項四、藥廠如何做好藥材源頭管理五、中醫藥委員會相關法令、最新公告六、探討歷年中藥材之異常物質背景值研究四場訓練課程原預計 200人次。但實際參加 303人次(不含講師)。課後有測驗,測驗成績達 70分以上為合格,授予本會受訓結業證書。 4場訓練合格人數共 286人,合格率 94.4%。課程滿意度調查,滿意以上占 93.7%。 |
英文摘要 | The main goals of the training courses were for included the QC of: aflatoxin, micro-organisms, pesticide residues, and heavy metals in Chinese medicine. Two continued practical courses were discussed and designed with CCMP, TFDA, and industry. Two different training courses (Ⅰ) and (Ⅱ) were held at at Kaohsiung & Taichung, and Tainan & Taipei. The topics of course (Ⅰ) were: 1. Heavy metals test methods and precautions to establish for Chinese herbal medicines. 2. The establishment of microbiological test methods and points to note for Chinese herbal medicines. 3. Pesticide residue testing methods and precautions to establish for Chinese herbal medicines. 4. Aflatoxin test methods and precautions to establish for Chinese herbal medicines. 5. The instructions and lab management for contaminations control. 6. Sharing the outsourcing experiences in QC/QA for Chinese herbal medicines. The topics of course (Ⅱ) were: 1. Sharing the experiences for the management of Chinese medicines manufacturing 2. Sharing the experiences for the quality control of Chinese medicines. 3. Points to note for quality control related to the particulate matter in GMP inspection for Chinese medicines manufacturing. 4. The management at the source for Chinese medicines manufacturing. 5. Introducing the update or new regulations on quality to Chinese medicine manufacturers. 6. Exception the value of the background of Chinese herbal medicines over the years. Even 200 attendees were scheduled; however, it came out as 303 people. The attendees needed to take a quiz to earn a certificate. Only 94.4% of the attendees past the test. The satisfaction survey showed more than 93.7% were satisfied. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。