Traditional Culture Encyclopedia - Traditional virtues - Drug business enterprises should take what measures necessary to ensure the quality of drugs

Drug business enterprises should take what measures necessary to ensure the quality of drugs

Pharmaceutical companies should take the necessary measures (anti-freezing, moisture-proof, insect-proof, refrigeration) to ensure the quality of drugs.

Pharmaceutical production licenses are divided into the person in charge of the enterprise, the scope of production, production address.

"Drug Manufacturing License" shall contain the license number, enterprise name, legal representative, the person in charge of the enterprise, the type of enterprise, registered address, production address, production scope, the licensing authority, the date of issuance of the license, the expiration date and other items. Which is approved by the drug supervision and management department of the license for: the person in charge of the enterprise, the scope of production, production address.

"Drug Manufacturing License" is divided into the original and a copy of the original, the copy has the same legal effect, the validity period of 5 years. Items such as enterprise name, legal representative, registered address, and enterprise type should be consistent with the relevant contents set forth in the business license issued by the administration for industry and commerce.

Enterprise name should be consistent with the principle of classification and management of drug manufacturers; production address in accordance with the actual production of drugs to fill in the address; license number and production scope in accordance with the State Food and Drug Administration to fill in the method and category.

Licensed pharmacists are responsible for providing drug knowledge and pharmaceutical services work.

Licensed pharmacists are:

1, compliance with national regulations and policies: strict compliance with the Chinese People's **** and the State Drug Administration Law and the State's drug development, production, operation, use of the various regulations and policies;

2, the relevant violations of the law to stop and advise and report to the regulatory authorities: violations of the Chinese People's **** and the State Drug Administration Law and the Relevant rules and regulations of the act or decision, have the responsibility to put forward to advise, stop, refuse to implement, and report to the local department responsible for drug supervision and management;

3, the development of management system and supervision and management of quality: responsible for the supervision and management of the quality of medicines, participate in the development and implementation of the overall quality management system of medicines;

4, participate in the internal violation of the work of dealing with: participate in the unit of the internal Violation of regulations to deal with the work;

5, audit prescriptions and provide information on the rational use of medication: responsible for the audit and dispensing of prescriptions, provide medication advice and information, guidance on the rational use of medication;

6, carry out drug monitoring and drug evaluation: to carry out monitoring of therapeutic drugs and drug efficacy evaluation of clinical pharmacy;

7, supervise the business and ensure that the norms: supervise the daily operations of the Pharmacy daily business and ensure that everything is in line with the norms;

8, from time to time offline consulting: from time to time to provide offline health lectures or store professional consulting;

9, do a good job of monitoring and feedback of medication: do a good job of monitoring the adverse drug reactions, medication errors and medication incidents, and timely collection, organization and feedback;

10, do a good job of hygiene work: Do the hygiene and cleanliness of the area in charge;

11, responsible for drug transfer and consultation: responsible for drug transfer, distribution and drug consultation.

Legal basis:

The People's Republic of China*** and the State Drug Administration Law

Article 2 In the People's Republic of China*** and the State of China within the territory of the development, production, operation, use and supervision and management of pharmaceutical activities, the application of this law.

Drugs, as referred to in this Law, are substances, including traditional Chinese medicines, chemical medicines and biological products, which are used for the prevention, treatment and diagnosis of human diseases, and for the purpose of regulating the physiological functions of human beings, as well as providing for indications or functional prescriptions, usage and dosage.

Article 3 The management of medicines shall be centered on people's health, adhere to the principles of risk management, whole process control and social ****governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of medicines, and safeguard the safety, efficacy and accessibility of medicines.

Article 4 The State develops modern and traditional medicines, giving full play to their role in prevention, medical treatment and health care.

The State protects wild medicinal resources and varieties of Chinese medicine, and encourages the cultivation of authentic Chinese medicinal materials.