1. An enterprise shall set up an independent quality management department to perform the duties of quality assurance and quality control. The quality management department may set up a quality assurance department and a quality control department respectively. The quality management department shall participate in all quality-related activities and be responsible for reviewing all documents related to this specification. Personnel in the quality management department shall not delegate their responsibilities to personnel in other departments.

2, the enterprise should be equipped with a sufficient number of management and operation personnel with corresponding qualifications (including education, training and practical experience), should clearly define the responsibilities of various departments and positions. Job responsibilities shall not be omitted, and overlapping responsibilities shall be clearly defined. Everyone should not bear too much responsibility. All personnel should be clear and understand their responsibilities, be familiar with the requirements related to their responsibilities, and receive necessary training, including pre-job training and continuing training.

GMP Good Manufacturing Practices

Quality management is the basic principle of drug production and quality management. It is suitable for the whole process of pharmaceutical preparation production and the key process affecting the quality of finished products in raw material production. Vigorously promoting GMP is to avoid pollution and cross-contamination in the process of drug production to the maximum extent, reduce the occurrence of various errors and improve the quality of drugs. Food production enterprises and pharmaceutical preparations are required to have good production equipment and strict testing system to ensure that product quality meets relevant standards.