Pharmaceutical Good Manufacturing Practice Regulations Article 139
Manufacturers shall establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records.Quality records of manufacturers and their control shall conform to the following requirements:(1) Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.(2) Pertinent quality records from the subcontractor shall be part of the records.(3) Quality records shall be retained for a period of time at least equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than two years from the date of dispatch from the manufacturer.(4) All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss.(5) Where agreed contractually, quality records shall be made available for evaluation by the customer for an agreed period.
中文原文 藥物優良製造準則第139條
製造業者應建立並維持書面程序，鑑別、蒐集、索引、取閱、建檔、儲存、維護及處理品質紀錄。
製造業者之品質紀錄及其管制，應符合下列規定：
一、品質紀錄應予保存，以證明產品符合規定要求與品質系統之有效運作。
二、品質紀錄，應包括分包商之品質紀錄。
三、品質紀錄之保存期限，應明文規定，並至少應與其醫療器材之有效期間相同，且不得少於自產品出廠後兩年。
四、品質紀錄應易於閱讀，且其貯存與保管方法應便於存取，並存放於適宜環境，防止損壞、變質、遺失。
五、如合約有約定者，品質紀錄應供客戶於約定期間內作評估之用。
製造業者之品質紀錄及其管制，應符合下列規定：
一、品質紀錄應予保存，以證明產品符合規定要求與品質系統之有效運作。
二、品質紀錄，應包括分包商之品質紀錄。
三、品質紀錄之保存期限，應明文規定，並至少應與其醫療器材之有效期間相同，且不得少於自產品出廠後兩年。
四、品質紀錄應易於閱讀，且其貯存與保管方法應便於存取，並存放於適宜環境，防止損壞、變質、遺失。
五、如合約有約定者，品質紀錄應供客戶於約定期間內作評估之用。