关于制剂设备验证的必要性及方法探讨

Discussion about the Need for Preparation Equipment and Methods of Verification

为了在制剂设备的应用中引进验证理论,从自制制剂的特殊性出发,论述了制剂设备验证的必要性和验证方法,规范了制剂设备的验证程序与验证范围。医疗机构应从本单位实际出发,使用最适合的方法、途径来开展有针对性的验证工作。

In order to introduce the application of the device to verify the theoretical formulation, made from the special nature of the formulation, discusses the need for preparation equipment Verification and validation methods, standardized verification and validation program preparation equipment range. Health authorities from the reality of the unit, using the most appropriate methods and ways to carry out targeted verification.