頁籤選單縮合
| 題 名 | 藥品優良製造規範(GMP)中藥部分解說及缺失說明=Explanation and Checking List for Good Manufacturing Practice (GMP) Chinese Medicine |
|---|---|
| 作 者 | 李威著; | 書刊名 | 中醫藥年報 |
| 卷 期 | 光碟版1:9 2012.10[民101.10] |
| 頁 次 | 頁708-799 |
| 專 輯 | 中醫藥產業實務規範 |
| 分類號 | 418.45 |
| 關鍵詞 | 中藥; 優良藥品製造規範; 條文解說; 缺失說明; GMP; Chinese medicine; Explanation and checking list; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 計畫目的:修正及新增目前藥品優良製造規範( GMP)有關中藥部分之解說及缺失說明專書,提升中藥廠對藥品優良製造規範(GMP)中藥部份之了解,減少業者於GMP查核之缺失,促進中藥產業升級。 研究方法:一、依據衛生署中醫藥委員會歷年已執行之二件藥品優良製造規範( GMP)中藥部分解說及缺失之研究計畫成果為藍本( CCMP90-CT-009、 CCMP94-CP-007),及歷年藥廠查廠缺失或較有爭議之查核問題,至少召開三次以上之專家學者座談會,研議修正與新增條文解說及查廠缺失項目,建立正確之藥品優良製造規範(GMP)中藥部分解說及缺失說明報告。二、 100年 10月底前辦理一場 100人以上之業者訓練課程,針對所研議之內容向業者說明並溝通意見,以避免因解讀上的差異而造成實務上之錯誤態樣,而影響產品品質。三、調查目前 GMP中藥廠之設備、環境、人力、品管檢測、製藥工程、工廠管理等背景情況與執行面之常見問題,並經由專家學者座談會研議其可行之因應方式,提供業者參考。四、製作 GMP中藥部分解說及缺失說明專書至少 150本,提供中藥廠在執行相關規定時參考。 結果:一、成立專家學者座談會計 20人,邀請產、官、學、研代表如勝昌、順天堂、科達、莊松榮、超群檢驗、良濟堂、京都念慈菴等業界代表,行政院衛生署食品藥物管理局研檢組、經濟部工業局、新北市衛生局等政府單位代表,台北醫學大學、中國醫藥大學、大仁科技大學等學界代表,醫藥工業技術發展中心、社團法人臺灣藥物品質協會、中華中草藥生技發展協會、臺灣區製藥工業同業公會等公協會 GMP專家組成,會中並邀請主管機關衛生署中醫藥委員會派員列席指導。二、依據衛生署中醫藥委員會歷年已執行之二件藥品優良製造規範( GMP)中藥部分解說及缺失之研究計畫成果為藍本( CCMP90-CT-009(1)、 CCMP94-CP-007(2)),及歷年藥廠查廠缺失或較有爭議之查核問題,共召開六次專家學者座談會,研議修正與新增條文解說及查廠缺失項目,建立較為適切之藥品優良製造規範(GMP)中藥部分解說及缺失說明報告。三、 100年 10月 27日於台南立康生物科技股份有限公司辦理業者訓練課程,與會人數共計 127人,包含 76家中藥廠派員參與,已占目前 116家 GMP中藥廠之 66%。針對專家學者座談會所研議之內容向業者說明並溝通意見。四、於業者訓練課程中,說明藥物製造工廠檢查辦法 (7)及製藥工廠基本資料(SMF)製備說明相關資料(8),做為中藥業者自主管理參考,建立中藥工廠基本資料,提升中藥廠管理的水準。五、完成製作 GMP中藥部分解說及缺失說明專書 150本,提供中藥廠在執行相關規定時參考。 討論與建議:本計畫的執行期間僅有短短的六個月,雖然在有限的時間限制下,一共開了六次的專家會議與二次會前會,將多年未討論修訂的條文解說及缺失內容,新增及修訂為符合現行法規規範與實際狀態,並提出多項建議事項。但由於時間有限,有些議題實無法深入討論,建議主管機關可以考量日後定期辦理相關議題的討論會議,將結果適時納入,以使中藥廠實務上符合、適用,是較為適切之方式,也可減少主管機關與業者查廠時於認知上的差異。 |
| 英文摘要 | OBJECTIVES OF THE PROJECT: The objectives of this project is to revise and add GMP explanation and checking list to reduce the possibility of making mistakes during GMP inspection and promote the development of the Chinese Medicine Industry. RESEARCH METHODS: 1. This project would base on two previous GMP projects (CCMP90-CT-009、 CCMP94-CP-007) to adjust the checking list and discuss some controversial issues on GMP inspection by holding at least three meetings with experts and scholars. Then complete the project report to make the correctness of the CMP explanation and checking list. 2. There will be a training session for more than 100 industry players attended by the end of the October in 2011. The purpose of holding this training session is to communicate with the industry players and then avoid the misunderstandings of the CMP explanation and checking list in this project, which may result in the effects of product quality. 3. There will be some inspections conducted regarding manufacturing facilities, environment, manpower, quality control, Chinese pharmaceutical manufacturing process and factory control. Then the experts and scholars would find the possible solutions for industry players as reference. 4. There are at least 150 books regarding GMP explanation and checking list would be provided to industry players as reference. RESULTS: 1. A group of 20 people from different backgrounds such as Chinese Medicine Industry players, officials, academics, and researchers would be formed to participate in the following symposiums and advisers from CCMP would be invited in the symposiums as well. 2. Base on two previous GMP projects (CCMP90-CT-009、CCMP94-CP-007), six symposiums have been held to help finish the project report regarding correctness of the CMP explanation and checking list. 3. On Nonmember 27th , 2011, a training session has been held in Li Kang Biotechnical Co., Ltd in Tainan with 140 people attended and 80 of them were industry players. 4. The Pharmaceutical Manufacture Inspection Measures and site master file to the industry players would be elaborated through the training session as reference of independent management in order to gather the basic information of manufacturing sites from individual pharmaceutical company. Therefore, it would enhance the level of manufacturing sites management. 5. 150 reference books regarding GMP explanation and checking list have been produced. DISCUSSION: Although this project has been executed under limited time of six months, six symposiums and two pre-meetings have been held. The emendations for explanation and checking list for GMP in this project have been made in accordance with the real situation and also some suggestions have been provided. Since the time is limited, some issues were not able to be discussed deeply. It is suggested that the competent authorities could consider holding meetings to further discuss about the related issues and then make it apply to the real situation in the coming future. Therefore, the recognition difference of GMP inspection between competent authorities and industry players would be reduced. |
本系統中英文摘要資訊取自各篇刊載內容。