Pharmaceutical Good Manufacturing Practice Regulations Article 67
Manufacturers shall establish and maintain records to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable.Manufacturers shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.Manufacturers shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the manufacturers but not less than three years from the date of product release by the manufacturers or as specified by other relevant regulatory requirements.
中文原文 藥物優良製造準則第67條
製造業者應建立與維持紀錄，以提供符合品質管理系統要求與有效運作之證據。
品質紀錄應保持清晰易讀、易於鑑別及檢索。
製造業者應建立鑑別、儲存、檢索、保護、保存期限及處理品質紀錄之書面管制程序。
製造業者保存紀錄之期限應至少相當於製造業者所規定之醫療器材有效期間，且不得少於產品從製造業者放行之日起三年，或按其他相關法規之要求。
品質紀錄應保持清晰易讀、易於鑑別及檢索。
製造業者應建立鑑別、儲存、檢索、保護、保存期限及處理品質紀錄之書面管制程序。
製造業者保存紀錄之期限應至少相當於製造業者所規定之醫療器材有效期間，且不得少於產品從製造業者放行之日起三年，或按其他相關法規之要求。