Validation Practice On The Manufacturing Process Of Veterinary Drug Premix

The article analysed the concept of manufacturing validation in the course of veterinary Pharmaceuticals GMP management,contrasted the application case of international and internal validation, discussed the the importance of validation on implementation of veterinary drugs GMP maagement and the key role of manufacturing process validation on all validation protocols ..We have put production process validation into practice through taking norfloaxin as an example. The result showed that the quality of product and the stablity of quality were promoted. We revised the previous validation program,making it conform to the need of actual production and providing an efficent reference for veterinary drugs GMP practice in our country.Drying process is related to the control of product moist and its stability. The test set up and validated any optimum parameters of drying process on the basis of confirmation of that ZRH-1C hot wind cycling oven worked regularly by the way of drying weightlessness. The result showed that the individual and average moist content of starch sampling spot and also coefficent of variation consistently conformed to the established standard and the requirement of manufacturing process by drying for 3 hours at 105℃.Mixing process is a key procedure to influence on the homogeneity that is related to the mixing time.The test screened optimum parameters of mixing process on the premise of established of mixing rotational speed and the way of adding material and the performance of VHJ-2000 mixing machine by the way of chemical analysis . The result showed that the shortest time of that the finished product gained the best homogeneity was at least 20 min when the mixing volume is 600kg.Packing process is a important element to guarantee the uniform of product and loading capacity. On the basis of confirmation of the performance of functional parts of automatic packing machine ,we adopted weighing and chemical analysis to validate the manufacturing procedure. The result demonstrated that the capacity of load accorded with the criteria of the Chinese Veterinary Pharmacopoeia and the homogeneity of finished product conformed to the set-up requirement of the production process.Through the validation of the above three key process of norfloaxin premix production ,it was demonstrated that the previously-established process parameters could guarantee that stable,qualified and homogenous productwas obtained .In general ,this production process could be put into practice.