The "cGMP Course for Active Pharmaceutical Ingredients" developed by USP is based on ICH Q7 and GMP practices, and effectively combines the quality system management approach with USP expert advice. Through the explanation of quality management systems, plant facilities and equipment, material systems, manufacturing systems, packaging and labeling, documentation and standard operating procedures, and process validation, Help enterprises systematically understand the requirements of drug manufacturing, FDA and other regulations on sub-systems, and ultimately help enterprises to reduce the risk of non-compliance with FDA regulations. In addition, in view of the actual situation of Chinese enterprises, this course makes enterprises have a deeper and more operable understanding of GMP through the comparison, case analysis and group discussion between the new Chinese GMP and ICH Q7.
Through this training, the employees of the enterprise understand more GMP knowledge, which is conducive to the enterprise in production management and quality management with the international better standards, but also for the end of this year can successfully pass the United States Pharmacopoeia USP certification laid a good foundation.