2? Check the operation. Check whether the corresponding equipment such as cabinet group, refrigeration equipment, temperature control equipment, etc. has a special person in charge, check whether the setting of cabinet group is reasonable, whether it is mixed and stored, whether the classification identification is clear and correct, and whether there is direct sunlight.
3? Check all kinds of records and forms. Commodity inspection records, maintenance records, temperature and humidity records, unqualified drug registration and disposal records, adverse reaction report records, expired drug reminders, etc. are also key items for inspection.
Extended data:
According to good manufacturing practice,
Article 5 An enterprise shall establish a quality management system, determine quality policies, formulate quality management system documents and carry out activities such as quality planning, quality control, quality assurance, quality improvement and quality risk management in accordance with relevant laws and regulations and the requirements of this Code.
Article 6 The quality policy documents formulated by an enterprise shall specify the overall quality objectives and requirements of the enterprise, and shall run through the whole pharmaceutical trading activities.
Article 7 An enterprise's quality management system shall be suitable for its business scope and scale, including organization, personnel, facilities and equipment, quality management system documents and corresponding computer systems.
Article 8 An enterprise shall regularly organize internal audits and organize internal audits when the elements of the quality management system have undergone major changes.
Article 9 An enterprise shall analyze the internal audit, formulate corresponding measures to improve the quality management system according to the analysis conclusions, continuously improve the quality control level, and ensure the continuous and effective operation of the quality management system.
Article 10 An enterprise shall evaluate, control, communicate and review the quality risks in the process of drug circulation in a forward-looking or retrospective way.
Article 11 An enterprise shall evaluate the quality management systems of drug suppliers and purchasers, confirm their quality assurance ability and quality reputation, and conduct on-the-spot investigations when necessary.
References:
Baidu Encyclopedia-Quality Management Standard for Pharmaceutical Business