Pharmaceutical Good Manufacturing Practice Regulations Article 115
Manufacturers shall conduct internal audits at planned intervals to determine whether the quality management system conforms to the following requirements:(1) Conforms to the planned arrangements, to the requirements of these Regulations and to the quality management system requirements established by the manufacturers; and(2) Is effectively implemented and maintained.Manufacturers shall establish an audit programme, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.Manufacturers shall define in a documented procedure the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records.The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.Follow-up activities shall include the verification of the actions taken and the reporting of verification results.
中文原文 藥物優良製造準則第115條
製造業者應在所規劃之期間內執行內部稽核以決定品質管理系統是否符合下列要求：
一、符合產品實現之規劃、本準則之要求及製造業者品質管理系統之要求。
二、有效地實施與維持。
製造業者應考量受稽核活動與地點之情況、重要性及先前稽核之結果，據以規劃稽核計畫。
應規定稽核準則、範圍、頻率及方法。
稽核員之遴選與稽核之執行，應確保稽核流程之客觀性及公正性。
稽核員不應稽核其本身之工作。
製造業者應以書面程序規定稽核之規劃與執行、結果報告及紀錄維持之權責與要求。
接受稽核之管理階層，應確保在無不當延誤情況下，採取措施以消除所發現不符合事項及其原因。
前項措施需包括所採取措施之查證與查證結果之報告。
一、符合產品實現之規劃、本準則之要求及製造業者品質管理系統之要求。
二、有效地實施與維持。
製造業者應考量受稽核活動與地點之情況、重要性及先前稽核之結果，據以規劃稽核計畫。
應規定稽核準則、範圍、頻率及方法。
稽核員之遴選與稽核之執行，應確保稽核流程之客觀性及公正性。
稽核員不應稽核其本身之工作。
製造業者應以書面程序規定稽核之規劃與執行、結果報告及紀錄維持之權責與要求。
接受稽核之管理階層，應確保在無不當延誤情況下，採取措施以消除所發現不符合事項及其原因。
前項措施需包括所採取措施之查證與查證結果之報告。