Pharmaceutical enterprises should manage suppliers in strict accordance with GMP requirements

[technical article of China Pharmaceutical network] the materials required for drug production directly affect the quality of products, so the management of material suppliers is one of the sources of production quality management of pharmaceutical enterprises, which should be managed in strict accordance with the requirements of GMP However, according to the industry, material supplier management has been a weak link in many pharmaceutical enterprises The author understands that in recent years, due to the poor management of material suppliers, accidents often occur in pharmaceutical enterprises, which will affect the production progress and lead to serious drug accidents, resulting in the safety of human life In the new version of GMP, there are 11 terms for supplier management However, in practice, pharmaceutical enterprises have more or less problems in terms of the responsibilities of the quality management department, the personnel responsible for the quality evaluation of material suppliers, small batch trial production of samples, supplier list, quality agreement, quality files, regular evaluation or audit Specifically, the main reasons are as follows It is understood that some pharmaceutical enterprises often pay little attention to supplier management, and some enterprises may standardize supplier management at the beginning, and then be more casual In signing the quality agreement, they are also very "careless", even if there are mistakes in the quality agreement, they do not pay attention to it In addition, some pharmaceutical enterprises have not established quality files for some suppliers, and the established quality files are incomplete and lack many items At present, the number of material suppliers in China is large and the level is uneven, which makes many pharmaceutical enterprises have no choice According to the industry, for the selection of suppliers, pharmaceutical enterprises should carefully check the list to determine whether there are any materials that have not been evaluated and qualified, or suppliers that lack quality standards, production address information and are not updated in a timely manner It is reported that every pharmaceutical enterprise has its own supplier management and operation rules, but some pharmaceutical enterprises have general operation rules due to their own management level is not enough Poor operability, the implementation process is relatively "perfunctory" As a result, many pharmaceutical companies do not know the deviation in the on-site quality audit Unwillingness to "spend money" on the evaluation of material suppliers and on-site quality audit is a step that cannot be ignored, but some pharmaceutical enterprises are lazy to do these works in order to save money For example, some pharmaceutical enterprises with low level of production quality management are unwilling to "spend money" in order to save costs, so they cooperate with the selected suppliers without evaluation and on-site quality audit If the consequence is light, it will have a little influence on the quality of drugs If it is serious, it will lead to poor quality of drugs and harm people's health The industry points out that there are some problems in the supplier management of pharmaceutical enterprises in the process of implementing the new GMP These problems are not independent, many of them are accompanied by each other Therefore, pharmaceutical enterprises must pay attention to the management of suppliers, and manage suppliers in strict accordance with the requirements of GMP For those pharmaceutical enterprises whose management level is not high, we can properly strengthen the training of relevant personnel of supplier management or recruit employees with rich management experience, which can not cause greater losses for "saving money" In addition, pharmaceutical enterprises can control the expenditure of supplier management and control the overall cost of the enterprise by means of joint auditing.