Pharmaceutical Good Manufacturing Practice Regulations Article 45
The manufacturing, control, shipping and sales records prescribed in Chapter 2 shall all be stored in suitable locations, made available for inspection, and used at least once a year in the assessment of product quality standards; aforesaid records shall be kept until one year after the expiration date of the batch of products or end products in question. However, records for products that do not require expiration dates shall be kept for three years after the date of dispatch of the batch of products or end products in question.When relevant competent authorities make inspections, they may photocopy, or copy by other means, the records described in Paragraph 1 or copies of aforesaid records.
中文原文 藥物優良製造準則第45條
本章所定有關製造、管制及運銷之所有紀錄，應保存於適當場所，以供稽查，並作為評估產品品質之依據；其保存期間，為該批產品或最終產品有效期間後一年。
但免於標示有效期間者，應保存至該批產品或最終產品出廠後三年。
前項產品品質之評估，應每年至少辦理一次。
但免於標示有效期間者，應保存至該批產品或最終產品出廠後三年。
前項產品品質之評估，應每年至少辦理一次。