Pharmaceutical Good Manufacturing Practice Regulations Article 134
Manufacturers shall establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by them to demonstrate the conformance of product to the specified requirements.The above inspection, measuring and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
中文原文 藥物優良製造準則第134條
製造業者應建立並維持書面程序，管制、校正並維護其用以證明符合規定之檢驗、量測及試驗設備（含測試軟體）。
前項檢驗、量測及試驗設備，應在確知其量測之不確定度，並符合所需量測能力時，始得使用。
前項檢驗、量測及試驗設備，應在確知其量測之不確定度，並符合所需量測能力時，始得使用。