以GAMP 5實作自動化系統確效-以某公司為例

The Implementation of Automatic System Validation using GAMP 5 Guide – An Example of a Company

顏炳吉(Ping-Chi Yen)

指導教授 ： 劉俞志

元智大學/資訊學院/資訊管理學系/碩士(2013年)

https://doi.org/10.6838/YZU.2013.00128

摘要

為了能達到與世界接軌，臺灣在1982年頒布與實施GMP（Good Manufacturing Practice）規範來協助國內生技產業的發展。然而，GMP並未提供明確的軟體確效作法。為了協助企業順利通過客戶稽核與審查，發展自身的確效方法及產出相關證明文件，對生技產業是非常重要。本研究目的是要建立一個軟體確效模型，並產出相關證明文件。本論文以GAMP 5為原則來建立確效模型及產生相關驗證文件，經由客戶稽核來驗證其執行成效。經由分析個案公司實務的經驗，以獲得生技產業在軟體確效作業之可行性做法，並發展自身的確效驗證模型。

關鍵字

確效 ； 電腦化確效 ； GAMP

並列摘要

In 1982, Taiwan enacted and implemented GMP (Good Manufacturing Practice) regulation to assist the development of domestic biotechnology industry in order to connect with the world. However, GMP didn’t offer the definite way of software validation. To assist enterprises to pass customers audit and review smoothly, it is very important to develop our validation method and generate related documents for Biotechnology Industry. The purpose of this research is to establish a software validation model and generate related documents. This thesis is based on the principles of GAMP5 to establish the validation model and generate related documents. And validate the execution outcome via the audit of customers. We can get a feasibility method on the software validation in the biotechnology industry and develop the own validation model.

並列關鍵字

Validation ； Computerized Validation ； GAMP

參考文獻

1. ISO, B., 13845 Medical devices-Quality management systems-Requirements for regulatory purposes. International Organisation for Standardisation, 2003.

3. FDA, U., CFR Part 11 Electronic Records; Electronic Signatures. US Food and Drug Administration, Rockville, MD, www. fda. gov.

6. Guideline, I.H.T., Quality risk management. Q9. Current Step, 2005. 4.

2. FDA, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff",Food and Drug Administration. 2002.

4. Manufacturing, A.W.G.T.G., Practice (GMP) Requirements, Part 2: Validation. Geneva: World Health Organization, 1997: p. 1-100.