本課程可登錄繼續教育時數 :14.4 小時
[臨藥繼字 第1080182號]

2019/3/30及 4/13，週六 (共計12小時)
我要預約/報名

新春早鳥特別優惠 : 3/15前完成報名且繳費者 享新春特別優惠價  (限額:10名)

【適合對象】

1. 藥品製造相關從業人員、有品保相關知能需求之從業人員、生技產業相關領域從業人員等。
2. 歡迎本學院2016~2018 QA系列課程之舊生參加本進階課程

【課程規劃專家&講師】張簡雅青 博士 (生達化學製藥總經理室協理&品質系統總監) 親授
【課程主題】
* 為維護學習品質及成效;主題研討課程之參訓學員需先依研討需求於上課前一週完成預習(備課)講師指定之相關資料,並繳交提問單或課前心得!

Week one 3/30  : 两個主題與GMP日常運作相關。

• US FDA Data Integrity and Compliance with Drug CGMP Questions and Answers , December 2018
• Questions and Answers on Current Good Manufacturing Practices – Control of Components and Drug Product Containers and Closures 

Week two 4/13 : 两個主題與上市後變更執行biowaiver相關

• ICH M9 Biopharmaceutical Classification System-based Biowaivers , June 2018
• Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

 
【教學大綱&研討方式】
 
本次研討包括四個主題
 
主題1 : US FDA Data Integrity and Compliance with Drug CGMP Questions and Answers , December 2018

 
課程內容:
* US FDA對於DI相關議題的Q and A
* 說明DI的定義及要求如: metadata, audit trail, ALCOA, …
* 說明GMP對DI的要求
* 如何符合DI的法規要求
* 補充說明生產單及微生物實驗室相關的DI議題
 
研討方式
* 課前請先行研讀該份DI guidance
* 討論互動式課程
* 導讀該份文件的重點
* 該份guidance之重點與日常運作之應用
* 常見DI議題討論
* Q and A


主題2 : Questions and Answers on Current Good Manufacturing Practices – Control of Components and Drug Product Containers and Closures
 
課程內容:
* QA 相關的議題討論，包括倉庫管理、物料抽樣、抽樣計畫、動物性來源
之原材料要求、避免原料病原菌污染、玻璃材料相關議題和原料分析方法出處等GMP相關議題
* US FDA 針對component and container closure 提出15個GMP議題:

1. Do the CGMP regulations permit the destruction of an internal quality assurance audit report once the corrective action has been completed?
2. Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?
3. A firm has multiple media fill failures. They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter.  Investigation did not show any obvious causes.  What could be the source of contamination?
4. How many containers of each component from each shipment must a firm sample and test to comply with the CGMP requirements for identity testing?  Do the CGMPs permit the identity test on a pooled, or composite, sample of multiple containers?
5. What methods of analysis are suitable for testing for melamine contamination in pharmaceutical components?
6. Does FDA require or recommend any special precautions or controls over the manufacturing of animal-derived drug ingredients to prevent contamination?
7. What are FDA’s primary concerns about pathogenic agent contamination of animal-derived drug ingredients?
8. What manufacturing contamination risks are presented by the different pathogenic agents?
9. What are some ways to minimize pathogenic agent contamination in incoming animal-derived raw material?
10. Are there control measures for minimizing pathogenic agent contamination in animal-derived drug ingredient manufacturing facilities?
11. What should drug manufacturers do to prevent formation of glass lamellae (glass fragments) in injectable drugs filled in small-volume glass vials? 
12. Are there any special processing or handling concerns for flexible intravenous (IV) solution bags?
13. What can IV drug manufacturers do to help prevent the loss of sterility due to compromised IV solution bag integrity during labeling? 
14. Must each batch of a United States Pharmacopeia (USP)-grade API be tested using the analytical procedures specified in the USP monograph? 
15. Who is responsible for analytically testing APIs to ensure they comply with their specifications and with USP requirements, if any? 
     
    研討方式:

* 課前請先研讀FDA website的資訊
* 採取互動式課程
* 討論15條GMP議題之重點
* 討論日常運作之常見GMP議題，例如:

1. 倉庫管理及抽樣之常見議題
2. 供應商資料與收貨程序之關連性
3. 有Warning letter 之供應商後續之購買問題
4. 第二來源主成份相關議題*其他衍生問題之討論

 
 
主題3 : ICH M9 Biopharmaceutical Classification System-based Biowaivers, June 2018
 
課程內容 :
*  BCS-based biowaiver approach 之相關規定
*  符合那些要求可以減少in vivo實驗
*  探討BCS I & BCS III biowaiver
*  Case Study:符合減少in vivo實驗之處方變更
*  In vitro dissolution 的要求
 
 
研討方式 :
*  課前請先研讀ICH M9的內容
*  採取互動式課程
*  討論何種情況可以減少in vivo 實驗
*  實際應用
*  變更管制與BE實驗之相關性
*  SUPAC IR 與本份guidance 之連結
 
 
 
主題4 :  Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
 
課程內容 :
* 這份guidance 結合August 1997, 以及 August 2015的两份 guidances。新的2018 guidance 說明BCS I & III 溶離試驗的要求。
* 探討BCS I & III溶解度的實驗設計。
* 探討ODT orally disintegrating tablet 是否適用?
* 探討Excipient 對於吸收是否有影響?
* 溶離試驗需注意事項
 
研討方式 :
*  課前請先研讀ICH M9的內容
*  採取互動式課程
* 說明guidance 內容及應用重點
*  BCS I and III 如何決定? 可以引用文獻?
* 附加研讀SUPAC IR, 變更是否重新執行BE? 如何引用這篇guidance 來進行biowaiver?
* 舉例說明處方變更的上下限
*  Homework: SUPAC IR
 
【上課時間】2019/3/30及4/13，共2週，12小時，週六9:30-12:30 / 13:30-16:30
【上課地點】台北市大安區復興南路二段237號5F  (科技大樓捷運站 出口旁) 
【課程費用】非會員  NT 9,600  / QA系列舊生續班 & 團體會員價  NT 8,400
早鳥優惠 : 3/15前完成報名且繳費者 享新春特別優惠價，只要:NT 8,000元整  (優惠名額有限)
【預約/報名】我要預約/報名
【諮詢專線】02-77003883 分機11或 分機12  歡迎來電
(注意事項:以上課程內容、開課日期、授課師資、上課地點..等; 本協會保有異動權，如有變動將會提前通知)