Quality Risk Analysis on Production of Pharmaceutical Grade Donkey-hide Gelatin in Shandong Province
Objective To put forward risk prevention and control measures for donkey-hide gelatin manufacturers in Shandong Province through summary of the inspection data and identification of the quality risks.Methods Statistical analysis was made on the defects of donkey-hide gelatin enterprises involved in the special inspection of donkey-hide gelatin from 2020 to 2022.According to the technological characteristics of donkey-hide gelatin,combined with relative literature,risk prevention and control measures were proposed.Results The inspected enterprises were not found the use of miscellaneous donkey-hide source,and was able to conduct the inspection of finished products in accordance with the standards listed in Chinese Pharmacopoeia(2020 Edition)and strictly implement GMP for quality management.The enterprises need to continually pay attention to personnel training,improve the construction of quality management system,standardize facility and equipment management,and strengthen confirmation and verification management.Conclusion The common problems about quality management in production of pharmaceutical grade donkey-hide gelatin in manufacturing enterprises of Shandong province are found,and the main risks are discussed,thus to provide reference for better implementation of GMP in pharmaceutical donkey-hide gelatin manufacturing enterpriseds.
万方数据
维普
