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| 題 名 | 中藥GMP實務及PIC/S GMP法規教育訓練=The PIC/S GMP Regulation and Practice Training Programs of Chinese Medicine Pharmaceutical Factory |
|---|---|
| 作 者 | 李威著; | 書刊名 | 中醫藥年報 |
| 卷 期 | 3 2014.12[民103.12] |
| 頁 次 | 頁(94)1-(94)37 |
| 分類號 | 413.03 |
| 關鍵詞 | 教育訓練; 性別分析; 職務分析; GMP; PIC/S GMP; Training sessions; Sexual analysis; Job analysis; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 本計畫為加強中藥製藥業者「中藥 GMP實務及 PIC/S GMP法規概念」,與從業人員對於 GMP法規解說理解,避免因解讀差異而產生實務上之錯誤態樣,以致影響產品品質,並順應世界潮流,了解 PIC/S GMP之法規規定;特舉辦 4場「中藥 GMP實務及 PIC/S GMP法規教育訓練」,以提升中藥廠實務人員 GMP及 PIC/S GMP法規概念。 課程內容由專家小組研議後,與衛生福利部中醫藥司、衛生福利部食品藥物管理署、經濟部工業局民生化工組、及臺灣藥物品質協會代表共同召開教育訓練課程會前會,確認教育訓練之課程重點、課程內容、講師與日期。 課程分為「檢驗設備與品質管理」及「廠房設施設備與品質管理」兩大階段,分別於台南、台北及台南、台中舉辦 4場次,每場次 12小時的教育訓練,並於課程前後給予相同題目之評量以評估學習成效。 本計畫之課程每一場次均有百人以上參加,總計 518人次。其中第一階段有 112個參加單位,第二階段有 95個參加單位。在兩階段的教育訓練課程中,皆有派員參加的共有 71個單位,其中包含 59家中藥廠(占目前 105家 GMP中藥廠之 56.2%)、5個政府單位(屏東縣、高雄市、新竹縣政府衛生局、衛生福利部中醫藥司及衛生福利部食品藥物管理署)及 7家其他單位(包含學校、生技廠及西藥廠)。 由參加學員之性別分析中顯示,第一階段課程女性學員參與比例遠高於男性學員,但第二階段課程兩性學員參與比例大致相當。職務分析中則發現第一階段參加的學員以品管人員及管理階層占多數,第二階段參加的學員以品管人員、管理階層、及製藥現場人員占多數。由滿意度問卷調查分析顯示,四場研討會的滿意度皆達九成以上。所有學員、藥師及公務人員之課後評量成績顯著提升,得知本計畫應已達成預定目標,幫助提升中藥廠人員 GMP及 PIC/S GMP相關知能。 |
| 英文摘要 | The purpose of this project is to explain the GMP and PIC/S GMP regulations. In order to avoid the impact of product quality due to different interpretation of GMP regulations and adapt to global trends, to understand PIC/S GMP's regulations, the four training programs were held to improve pharmaceutical personnel’s knowledge. The course content was planned by Expert Group. The course feature, course content, lecturers and date of the training sessions were planned by some members from Food and Drug Administration, Department of Chinese Medicine and Pharmacy, Ministry of Health and Welfare; Industrial Development Bureau, Ministry of Economic Affairs; Taiwan Product Quality Research Institute. The training sessions were divided into 2 parts, “The Inspection Equipment and Quality Management” and “The Plant Facility and Equipment and Quality Management”. The training sessions have been held in Tainan, Taipei and Tainan, Taichung, four training sessions in total, and each course consists of 12 hours. Before and after lecture, same assessment has been given to attendants to assess their achievements. There were more than 100 people attended in each training session, a total of 518 participants. In the first stage, there are 112 units attended this training session; in the second stage, there are 95 units attended this training session. There are 71 units attended both training sessions; 59 of them are Chinese medicine manufacturers (accounting for 56.2% of the 105 GMP Chinese medicine manufacturers); 5 of them are from Government Institutions (Public Health Bureau of Pingtung, Kaohsiung, and Hsin-Chu County and Food and Drug Administration, Ministry of Health and welfare); 7 of them are from others (included schools, biotechnology companies, and western pharmaceutical manufacturers). The assessment results have showed that the attendants have learned some knowledge regarding GMP regulations, so the goal of this project has achieved. In addition, more female participants attended in the first stage; and the proportion between male and female participants in the second stage training session is nearly equal. All the attendants were sorted by job; the results showed that there are more quality control personnel and management personnel in the first stage; and more quality control personnel, management personnel, and pharmaceutical personnel in the second stage. Over 90 per cent of attendants were satisfied with the four training programs according to the after course satisfaction survey. |
本系統中英文摘要資訊取自各篇刊載內容。