Pharmaceutical Good Manufacturing Practice Regulations Article 66
Documents required by the quality management system shall be controlled. These include but not limited to any type of documented records, which shall all be controlled according to the requirements of these Regulations.Manufacturers shall establish a documented procedure that includes the following, to define the controls needed to:(1) Review and approve documents for adequacy prior to issue;(2) Review and update as necessary and re-approve documents;(3) Ensure that changes and the current revision status of documents are identified;(4) Ensure that applicable documents are available at points of use;(5) Ensure that documents remain legible and readily identifiable;(6) Identify documents of external origin and control their distribution; and(7) Prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for necessity.Manufacturers shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions.Manufacturers shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the manufacturers, but not less than the retention period of any resulting record, or as specified by regulatory requirements.
中文原文 藥物優良製造準則第66條
品質管理系統應管制所需之文件，包含但不限於書面紀錄之類型，均應依據本準則之要求予以管制。
製造業者應建立書面紀錄文件之管制程序，包括以下事項：
一、審查、核可文件之適當性後予以發行。
二、必要時，審查與更新文件，並重新核定之。
三、鑑別文件之變更與最新版本之狀態。
四、在使用場所備妥適用之文件。
五、確保文件易於閱讀與鑑別。
六、鑑別外來原始文件並管制其分發。
七、防止誤用失效文件，如有必要保留此等文件時，應予適當鑑別。
製造業者應確保文件之變更，係經由原核可部門或其他指定部門之審查與核可，審查之部門應取得相關背景資料以利審查。
製造業者應保存至少一份失效之管制文件，並明定其保存期限。
該期限應確保在製造業者所規定之醫療器材有效期間內，可取得此醫療器材製造與測試之文件，且不得少於紀錄或相關法規要求所規定之保存期限。
製造業者應建立書面紀錄文件之管制程序，包括以下事項：
一、審查、核可文件之適當性後予以發行。
二、必要時，審查與更新文件，並重新核定之。
三、鑑別文件之變更與最新版本之狀態。
四、在使用場所備妥適用之文件。
五、確保文件易於閱讀與鑑別。
六、鑑別外來原始文件並管制其分發。
七、防止誤用失效文件，如有必要保留此等文件時，應予適當鑑別。
製造業者應確保文件之變更，係經由原核可部門或其他指定部門之審查與核可，審查之部門應取得相關背景資料以利審查。
製造業者應保存至少一份失效之管制文件，並明定其保存期限。
該期限應確保在製造業者所規定之醫療器材有效期間內，可取得此醫療器材製造與測試之文件，且不得少於紀錄或相關法規要求所規定之保存期限。