Therefore, Taigu Guangyuan Tang Pharmaceutical Co., Ltd. solemnly promises:
First, strictly implement the Drug Administration Law, the Regulations on the Implementation of the Drug Administration Law and other laws and regulations, and organize production, operation and use in accordance with the requirements of the good manufacturing practice. Testing and inspection shall be carried out in strict accordance with the requirements of the current edition of China Pharmacopoeia.
Second, in strict accordance with the requirements of the Notice on Strengthening the Supervision and Management of Chinese Herbal Pieces issued by the US Food and Drug Administration, the Ministry of Health and state administration of traditional chinese medicine (20x25 Commitment on Drug Quality and Safety issued by the US Food and Drug Administration), we will not subcontract or change the packaging label of Chinese Herbal Pieces, semi-finished products or finished products. Do not buy Chinese herbal medicines from units or individuals that do not have the business qualification of Chinese herbal medicines.
Third, strictly conduct quality audits and on-site audits of suppliers to improve the quality standards of internal control of enterprises.
Our company voluntarily accepts the supervision of peers and society. In case of violation of laws and regulations, the enterprise will bear corresponding legal responsibilities and corresponding consequences.
XX company
20XX year XX month
Drug Quality and Safety Commitment 2 In order to ensure the quality of drugs and ensure the safety of public medication, our company, as the first person responsible for drug quality and safety, solemnly promises:
First, strictly abide by the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law and other laws and regulations, standardize business practices in accordance with the requirements of the newly revised Quality Management Standard for Pharmaceutical Trading, take full responsibility for the quality and safety of the drugs handled, and ensure that counterfeit and inferior drugs are not handled.
Two, in accordance with the "drug business license" permitted by the way and scope of business. Effectively implement various quality management systems, do not buy, sell, lease or lend the Drug Business License or the counter, do not change the contents of the license without authorization, and do not operate drugs beyond the scope. Don't post false advertisements inside and outside the store, don't sell false advertising products, don't participate in any drug promotion that exaggerates the curative effect and misleads consumers, and don't impersonate non-drugs to defraud consumers.
The third is to strictly control the quality of drug procurement, ensure that drugs are purchased from legally qualified suppliers, obtain invoices, and ensure that the purchased drugs are entered into the computer system after batch acceptance and sold on shelves. Earnestly implement the system of quality inspection and acceptance of incoming goods to ensure that tickets, accounts and goods are consistent.
Four, in strict accordance with the requirements of drug classification management regulations, to ensure that the resident pharmacists are on the job during business hours, not open-shelf sales of prescription drugs. When the resident pharmacist is not on duty, he will be listed and told to stop selling prescription drugs. Publicize and guide rational drug use and attach importance to consumer complaints. Sales of drugs take the initiative to issue sales vouchers in line with state regulations.
Five, strictly implement the state regulations on the management of compound preparations containing special drugs. Do not engage in egg peptide preparations (except insulin), prescription drugs such as mifepristone and compound preparations containing codeine for contraception and termination of pregnancy.
Six, strengthen the use of computer management system. Formulate corresponding rules and regulations and operating procedures, and designate special personnel to use and maintain the computer management system; It can cover the whole process of business quality control in all aspects of drug procurement, storage and sales of enterprises; Can accept the real-time online monitoring of drug business by food and drug supervision and management departments.
Seven, seriously carry out the monitoring and reporting of adverse drug reactions, and report serious suspected adverse drug reactions to the drug regulatory authorities within 24 hours.
Eight, strict self-discipline, take the initiative to accept and actively cooperate with the supervision and management of food and drug supervision departments, consciously accept the supervision of all sectors of society and consumers, do not resort to deceit, do not evade supervision.
Name of medical institution (seal):
Commitment (legal representative or person in charge of the enterprise):
Contact telephone number:
Commitment date: 20xx year x month x day
Commitment letter 3 on drug quality and safety more comprehensively, accurately and fully performs the management functions of comprehensive food safety supervision and drug supervision, and effectively protects people's food safety and drug safety. Recently, the US Food and Drug Administration in Pukou, xx, made a solemn commitment to the whole society on the basis of "A Letter to the People of the Region", inviting all sectors of society and the people to supervise:
First, adhere to administration according to law and strictly enforce the law. Earnestly perform their statutory duties, organize and carry out special food safety rectification, vigorously rectify and standardize the order of the drug market, severely crack down on illegal and criminal activities such as manufacturing and selling counterfeit and inferior drugs and medical devices, and create a safe and secure environment for the public to eat and use drugs. Implement daily supervision, administrative licensing, administrative punishment and administrative compulsory measures according to law, so that laws are strictly observed and violators are prosecuted.
Second, adhere to clean politics and enforce the law impartially. Resolutely implement the "Several Provisions of the US Food and Drug Administration on Fair Law Enforcement and Honesty in Politics" and strictly manage the law enforcement team. This article comes from. It is strictly forbidden to make things difficult, delay, deliberately fail to act or act indiscriminately, seek personal gain by card, and participate in drug production and business activities. Violators shall be seriously investigated for the responsibility of relevant personnel according to law and discipline.
Third, adhere to standardized procedures and efficient law enforcement. Perform supervisory duties in strict accordance with legal procedures, and conscientiously implement the administrative law enforcement responsibility system and accountability system. When accepting reports, we should do "every report must be received, every complaint must be investigated, and every result must be investigated", and the administrative license is "centralized acceptance, one-time notification, and time-limited completion".
Fourth, adhere to enthusiastic service and civilized law enforcement. Strictly abide by the service commitment system and the first question responsibility system, behave in a civilized manner and behave in a standardized manner. Through the openness of government affairs and e-government, we will actively improve and change our work style, and earnestly serve the people, facilitate the people and benefit the people. Establish the consciousness that development is the first priority, handle the relationship between supervision and development, and make positive contributions to the sound and rapid development of pharmaceutical economy in our region.
Commitment to drug quality and safety 4 In order to conscientiously implement the requirements of national drug management laws and regulations, earnestly fulfill the responsibility of drug production enterprises as the first person responsible for drug quality and safety, standardize drug production and operation behavior, and effectively ensure the safety of the use of medical oxygen provided to users, this unit makes the following commitments:
1. Strictly implement the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law, the Special Provisions of the State Council on Strengthening the Safety Supervision and Management of Food and Other Products, and the Regulations on Drug Supervision and Management of Shanxi Province, and distribute medical oxygen in strict accordance with the requirements of national, provincial, municipal and district food and drug supervision and management departments, without violating laws and regulations.
2. Strictly implement the requirements of good manufacturing practice, improve the drug quality assurance system, strengthen internal quality management, revise and improve various rules and regulations, ensure the quality of medical oxygen packaging, and standardize the sales behavior of enterprises.
3. Strengthen the management of medical oxygen to prevent improper circulation of medical oxygen. Strictly implement the relevant provisions of the state and provincial food and drug supervision and management departments.
4. Strictly control the procurement quality of raw material medical liquid oxygen, strictly examine the production and operation qualifications of suppliers, obtain and save the relevant certificates, materials and sales vouchers of suppliers, and ensure that raw material medical liquid oxygen is not purchased from units or individuals that do not have the production and operation qualifications of medical liquid oxygen, and is not purchased or used by unqualified suppliers without authorization.
5. Strictly implement the acceptance system of medical liquid oxygen storage to ensure the traceability of raw materials. The storage of medical liquid oxygen (cryogenic liquid storage tank) should be checked and accepted one by one to verify the quality of medical liquid oxygen and establish a true and complete procurement record of medical liquid oxygen; Those that do not meet the specified requirements shall not be put into storage, used or returned.
6. Strictly implement the storage and maintenance system of medical liquid oxygen, take necessary measures such as dust prevention and pollution prevention, and keep maintenance records of low-temperature liquid oxygen storage facilities to ensure the safety and effectiveness of medical oxygen storage quality.
7. Carry out filling management in strict accordance with the packaging technology of medical oxygen registered by the company, carry out ex-factory inspection on the packaged medical oxygen in strict accordance with the current standard (oxygen in China Pharmacopoeia), and establish a true and complete batch production record; Those that do not meet the specified requirements shall not be put into storage or sold.
8. Sell qualified medical oxygen to the society, and establish a true and complete sales record with traceability. Establish and improve the reporting system of adverse drug reactions, and ensure that when adverse drug reactions are found, they are reported to the adverse drug reaction monitoring institutions and food and drug supervision departments in a timely manner. If it is found that there are potential safety hazards that may cause harm to human health and life safety, it shall immediately stop using the products, recall the products in strict accordance with the Measures for the Administration of Drug Recall, notify the medical liquid oxygen suppliers, and report to the food and drug supervision department.
9. Medical oxygen shall be repackaged according to Appendix: Medical Oxygen of good manufacturing practice. The repackaged medical oxygen shall be approved and issued by the food and drug supervision department, and the quality inspection shall be carried out according to the regulations.
10, take the initiative to accept and actively cooperate with the supervision and guidance of the food and drug supervision department, and consciously accept the supervision of all sectors of society and consumers. If you violate the above commitments, deliberately evade supervision and cheat, all the consequences and responsibilities arising therefrom will be borne by our unit, and we will actively cooperate with and accept the administrative handling by the food and drug supervision department.
Hereby promise!
Name of medical institution (seal):
Commitment (legal representative or person in charge of the enterprise):
Contact telephone number:
Commitment date: 20xx year x month x day