It is legally produced, up to standard, legally operated and properly stored.
1, this specification is the basic criterion for drug management and quality control. Enterprises should take effective quality control measures in drugs and other links to ensure the quality of drugs.
2. This specification shall be strictly implemented. Pharmaceutical production enterprises selling drugs and other drugs involved in storage and transportation in the process of drug circulation shall also meet the relevant requirements of this specification.
3, pharmaceutical enterprises should adhere to
4. Enterprises shall establish and 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 specification.
5. Our quality policy is: Our quality goal:.
6, enterprises should regularly and when the key elements of the quality management system have undergone major changes, organization.
7. Enterprises should evaluate the quality management system of drugs, confirm their quality assurance ability and quality reputation, and conduct on-the-spot investigations when necessary.
8. Be fully responsible for the daily management of the enterprise, provide necessary conditions to ensure that the quality management department and quality management personnel effectively perform their duties, ensure that the enterprise achieves the quality objectives, and operate drugs according to the requirements of this specification.
9. Be fully responsible for drug quality management, perform their duties independently, and have the right of adjudication on drug quality management within the enterprise.
10, the person in charge of the enterprise should have a degree or be trained in basic pharmacy knowledge, and be familiar with the relevant laws and regulations on drug management and this specification.
1 1. The person in charge of enterprise quality should have experience in quality management and have the ability to correctly judge and ensure implementation in quality management.