Three pharmaceutical companies were notified, and a number of common defects were exposed

[China Pharmaceutical network industry trends] on January 18, 2019, the State Drug Administration issued a continuous report on the flight inspection and handling results of three pharmaceutical companies   From the perspective of the problems found in the inspection, there are mainly problems that the quality management department can not strictly perform the relevant responsibilities; the QC laboratory management does not meet the requirements; the batch production records are incomplete, which can not reflect the whole production process; the material quality control and management do not meet the requirements; the product verification and technology verification do not meet the requirements; the product is produced and sold before the GMP certificate is obtained; The product sterility test does not meet the requirements; the production process control does not meet the requirements and other issues According to the above problems, the author found out the relevant basis Hope to have reference to the industry In terms of the relevant responsibilities of the quality management department, according to the 2010 version of the pharmaceutical production quality management specification, the quality management department shall be independent of other departments and perform the responsibilities of quality assurance and quality control In terms of QC laboratory management, GMP management is one of the important factors to ensure that the drugs produced are suitable for the intended use and meet the requirements of drug standards and regulations Therefore, its management must be paid attention to In terms of batch production records, the "drug production quality management specification" stipulates that each batch of drugs shall have batch records, including batch production records, batch packaging records, batch inspection records, drug release audit records and other records related to this batch of products The drug administration law makes it clear that, in addition to the processing of Chinese herbal pieces, drugs must be produced in accordance with the national drug standards and the production process approved by the drug regulatory department under the State Council, and the production records must be complete and accurate In the aspect of material quality control and management, material management is an important part of drug quality management system According to the pharmaceutical production quality management specification, in terms of quality control of materials, the internal standards of enterprises are required to be as detailed and tested as possible, and physical standards can be established if necessary Analyze the trend of inspection data of key indicators in quality standard to determine the fluctuation of material quality In terms of product verification and process verification, GMP stipulates that the production verification of drugs shall include the confirmation of plant, facilities and equipment installation, operation, performance and product verification The production process, key facilities and equipment of the product shall be verified according to the verification scheme When the main factors affecting product quality, such as process, quality control method, main raw and auxiliary materials, main production equipment, etc., change, and after a certain period of production, re verification shall be carried out In terms of product sales, it is required that the products of the enterprise should be sold after obtaining the GMP certificate In terms of sterility requirements, it is mentioned in the appendix of the new GMP that the production of sterile drugs must meet the requirements of their quality and intended use, so as to greatly reduce the pollution of microorganisms, various particles and pyrogens The skills, training and working attitude of the production personnel are the key factors to achieve the above objectives; the production of sterile drugs must be carried out in strict accordance with the carefully designed and verified methods and procedures, and the sterility or other quality characteristics of the products must not rely on any form of final treatment or finished product inspection   In addition, the purpose of production process control is to stably produce products that meet the quality standards approved by the registration standards according to the process of registration standards, i.e "ensure that the quality of drugs meets the intended use" Therefore, the quality control system of the production process should ensure that: the production process is consistent with the registered technology; the production process is stable; the product quality meets the intended use; the product quality is stable; and Certification of cleanliness of production plant, reduction of operation risk of personnel, etc.