A Brief Discussion On The Application Of Pharmaceutical Production Quality Management Measures

Drug quality and safety is not only related to corporate reputation and future development, but also closely related to people’s health. If drug safety and quality cannot be guaranteed, it will cause huge hidden dangers to social and economic development. Drugs are important commodities for the treatment of diseases for the public, and their quality is closely related to the health status of patients. This is also a key factor for the healthy development of pharmaceutical companies. To ensure that drug quality meets the requirements, it is necessary to do all the details of drug production, strictly supervise the production of each process, and implement all-round and multi-angle supervision and control of drug quality. Introducing a quality management system into pharmaceutical production can effectively promote the healthy development of pharmaceutical companies. Therefore, in the production process of drugs, control must be strengthened to ensure that drug quality and safety meet specified requirements.

At present, management concepts are embedded in various fields, especially in industries with higher risk indexes, and the use of management is more in-depth. The current economic development trend of globalization is both an opportunity and a challenge for our country’s social economy. Therefore, our country’s pharmaceutical companies have entered a golden stage of development. As a special product, medicines are used to treat and prevent various diseases, so the quality of medicines is related to people’s health. By improving drug management capabilities and supervision levels, we can to a certain extent ensure the health of patients and indirectly promote the healthy and stable development of the pharmaceutical industry.

Part 1 The Importance Of Strengthening Drug Quality Management

Currently, people are paying more and more attention to the concept of healthy living, and medicines have become an indispensable part of life. Its function can not only prevent diseases, but also effectively regulate various functional indicators of the human body, improve people’s quality of life and improve health. Especially in recent years, serious quality and safety problems have arisen in some drugs, which has discredited the pharmaceutical industry to a certain extent, reduced the credibility of enterprises and industries, and caused people to doubt the quality and safety of drugs. The main factors that cause safety hazards in drug quality are the weak safety awareness of drug companies, lack of supervision and management mechanisms, and inadequate implementation, which ultimately affects the safety and quality of drugs. Therefore, in the production of drugs, relevant companies should actively carry out quality supervision work to effectively improve the quality of drug production. Only through this can we ensure that each production link of the drug is well managed and controlled, and that the quality of the drug meets national requirements and ensures that The effectiveness and safety of medicines play a role in preventing and treating diseases, helping people improve human body functions, treat diseases and improve their quality of life.

Since the opening of the pharmaceutical market, the scope of pharmaceutical circulation has greatly increased, but it has also triggered very serious unhealthy competition. Through investigation, it was found that individuals purchase and sell drugs by affiliated with regular pharmaceutical companies and based on the business qualifications of pharmaceutical companies. Invoices are also issued by affiliated with the company. This method creates an environment for the sales of counterfeit and substandard drugs to a certain extent. Chance. At the same time, in some enterprises with imperfect internal control mechanisms, operators do not pay enough attention to management, blindly pursue economic interests, do not have adequate quality control management, and only purchase some low-cost drugs. However, the quality management department has not traced the quality and source of drugs, and the pharmaceutical authorities have not implemented supervision on the performance of their duties. Therefore, this has triggered a series of drug quality and safety issues.

The skills of drug distribution service personnel are low, they do not have pharmacist qualification certificates, they do not know how to test the quality of drugs, and they do not know how to maintain drugs, which has led to some drug quality and safety problems. The company does not implement regular training in place, employees have weak legal awareness, and their ability to control drug quality is weak. Internal controls are in name only, the drug inventory is just a formality, the number of drugs in stock does not match the book records, and some drugs that have expired and have damaged internal and external packaging have been left unprocessed for a long time. These are the main influencing factors that lead to drug quality and safety problems. Therefore, drug distribution companies must strengthen the control of purchasing, warehousing, management, sales and other aspects. Only in this way can the quality and safety of the drugs they handle be ensured.

Part 2 Application Of Pharmaceutical Production Management And Quality Risk Management

2.1 Specific Methods To Control Risks

Strengthening risk control can be implemented from many aspects such as software, hardware and personnel quality. First of all, in terms of software, it is necessary to establish and improve relevant documents and rules and regulations, strengthen management and control of document formulation and execution and other procedures, and implement a double review working mechanism. Secondly, in terms of hardware, we should focus on conducting research on the factory environment, basic equipment, raw materials, etc., carry out comprehensive and detailed research on factors affecting drug quality, and formulate and implement targeted response strategies, such as supplier qualification verification, Maintenance and treatment of production equipment, comprehensive inspection of the production site, etc. Third, in terms of personnel quality, production personnel must strengthen their professional abilities and professional qualities. Enterprises must regularly carry out on-the-job training to solve existing problems, make up for shortcomings and deficiencies, and improve professional standards in personnel recruitment. New employee training must be implemented regularly, and quality risk management and control mechanisms must be strictly implemented.

2.2 Practical Measures To Control Risks

When formulating risk control measures, enterprises must strictly follow the following three principles. First, effectiveness. This means ensuring that the measures formulated must be targeted and can strengthen the control of risks from the source and curb the occurrence of risks. The second is controllability. It means that the measures formulated must be significantly operable and be able to effectively control and solve problems. The third is significant effects. After the implementation of risk control measures, we must strictly prevent the occurrence of various safety problems, make up for the problems and shortcomings, and focus on strengthening the control of drug quality and safety, in order to achieve significant results.

2.3 Process For Reviewing Risks

Audit risk is the most important and final link in the quality risk control system. The risk management of the entire process needs to be inspected and audited, especially the production links that affect drug quality, which should be comprehensively and strictly inspected and audited. Risk management is an important part of quality control and should be implemented for a long time. Therefore, a scientific and comprehensive review system should be developed to conduct a comprehensive and systematic review of the factors affecting quality, refer to the risk level, and build a targeted review cycle. At the same time, reagents and personnel should be replaced regularly, paper notices should be issued and made public, and possible risks should be dealt with scientifically.

Part 3 Optimization Measures For Quality Management

3.1 Improve The Construction Of Infrastructure

For pharmaceutical companies, they must increase capital investment to improve infrastructure. It is necessary to ensure that the environment surrounding pharmaceutical production is excellent, and at the same time, the factory floor must be kept clean and tidy, the roads must be kept smooth, and the transportation vehicles must be pollution-free. Do a good job in maintaining the factory and disinfect the factory in strict accordance with regulations and requirements. Quality control laboratories and production areas must be strictly divided to strictly prevent cross-contamination. Highly infectious biological samples and radioactive items must be stored separately. Storage requirements must meet relevant national regulations. At the same time, sensitivity control of various production equipment must be strengthened. Equipment must be anti-static, anti-vibration, and moisture-proof. Waiting for some interference factors to be dealt with.

Finally, various infrastructure and production equipment must be cleaned and maintained regularly to strictly prevent the quality and safety of drugs from being affected by the existence of pollution sources.

3.2 Procurement Link Control

As a part of drug circulation, procurement has an extremely important impact on the quality of drugs. This also makes procurement work strict and cautious. Whether a drug distribution company will eventually purchase a certain drug depends on whether the drug can go through the corresponding process in strict accordance with the standards of the distribution company, such as whether the qualification inspection of the purchaser and supplier is qualified, whether the relevant quality guarantee certificate is standardized, etc. In addition, the drug data provided by the supplier must be important certification information, such as drug name, type, quantity, production date and expiration date. The manufacturer’s information includes unit, amount, detailed circulation costs, accounting details, etc. All of the above are things that circulation companies need to identify one by one. Doing so can ensure the quality and safety of drugs to a great extent, ensure that the sources of drugs are reliable and their effectiveness is obvious.

3.3 Strengthen The Approval And Supervision Of New Drugs

Tracing the source is the fundamental way to solve the problem. To this end, pharmaceutical companies must start from the source of new drug approval and strengthen the quality supervision and management of drugs. New drug approval is a step before drugs enter the consumer market and is a step in drug supervision. Effective supervision of new drugs can help ensure the quality and safety of the drug market and improve consumers’ trust in drugs. For this reason, strict review and management of drugs is an important part of the work of the drug supervision and administration department. Once safety hazards cannot be discovered in time during the approval process, new drugs will have an important impact on consumers after they enter the market, and relevant penalties will also follow. This will lead to unnecessary market chaos.

3.4 Establish A Reasonable Management Organization And Strengthen Employee Training

The person in charge of the enterprise shoulders the important responsibility of drug quality control and needs to strengthen internal control in manpower, capital, material and other aspects to fully ensure the quality of drugs. To this end, it is necessary to carry out layer-by-level checks in department settings, through specialized departments, such as quality management, raw material procurement, finished product sales, logistics transfer and company finance departments, to ensure that each department has a clear division of labor and specific responsibilities, ensuring that everything from production to circulation is All links are interlocking and orderly. Pharmaceutical companies need to set up qualified weight management departments in accordance with the requirements of the State Food and Drug Administration to ensure the quality and safety of drugs through inside-out supervision and management. Practitioners in specific departments must also raise requirements and standardize operations. To this end, companies need to strictly control talent recruitment, require the human resources department to strictly screen the ability of quality management department job applications, and control the overall level of employees in terms of academic qualifications, majors, and work experience. In addition, those who successfully pass the exam and enter the department also need to undergo strict training and re-education to ensure that they can improve their professional abilities and standards while ensuring that they are qualified for the basic job requirements, protect the company’s drug quality, and carry out corresponding tasks efficiently. management work.

Enterprises should set up a professional quality management department to clearly explain the content of quality management and quality assurance. The quality management department is mainly responsible for the quality control of pharmaceutical production and the management and review of relevant documents. Make clear instructions on the job responsibilities of each personnel, and implement quality control tasks on everyone according to regulations. Pharmaceutical companies should provide detailed explanations of the work tasks of managers. In order to prevent managers from muddling along, they need to issue scientific and complete operating guidelines to ensure the independence of quality control work and prevent quality control work from being interfered by other personnel. Drug quality should be managed by dedicated personnel, who should attach great importance to daily control work. In order to achieve the goals of quality control, the person in charge of the company needs to provide sufficient material support, formulate scientific management policies, and ensure that the quality management department can play its corresponding functional role. The quality and skills of production management personnel should meet the requirements to ensure that they are familiar with relevant operating procedures and industry regulations before taking up the job, and have professional qualifications and professional abilities. They should also receive targeted training to ensure that the training content is consistent with the job requirements. Clarifying the laws and regulations for food and drug production and strictly implementing relevant procedures as required are important links in ensuring the improvement of drug quality, helping to develop skills and improve training effectiveness.

3.5 Classified Management Of Pharmaceutical Companies

At present, there are widespread uncontrollable risk factors in production among pharmaceutical companies in my country, which is also a common phenomenon in the market. Whether the quality of drugs is strictly monitored is the key to controlling risks, and enterprises need to pay attention to the management concept of “risk theory”. To this end, relevant government departments should issue corresponding regulations and items, actively guide pharmaceutical companies to pay attention to the control and prevention of drug quality risks, and use scientific management methods and management methods to ensure the evaluation and control of drug quality. For pharmaceutical companies in different regions Strict control and scientific classification management. The implementation of classified management of pharmaceutical companies can improve the quality control level of high-risk pharmaceutical companies, and can also strengthen the control of production licenses of higher-risk pharmaceutical companies. High-risk pharmaceutical production and market circulation projects must be strictly restricted. Qualifications for pharmaceutical manufacturing. And strengthen the access norms and standards of the pharmaceutical industry, so that companies can continuously improve their professional capabilities and industry standards in order to obtain more market profits, strengthen their own development and construction, and always demand themselves with higher standards.

3.6 Strengthen Safeguard Measures

(1) Strengthen organizational leadership functions. All provinces, cities and regions must effectively ensure the political responsibility of drug safety, especially vaccine safety, implement the joint responsibilities of the party and government, and ensure that they are responsible for and fulfill their responsibilities in protecting the territory.

(2) Optimize the governance system, actively implement the drug safety responsibility system, and enhance the self-discipline awareness of industry associations. We should do a good job in coordinating drug supervision units, strengthen data sharing on drug supervision, medical control, and medical insurance control, improve the efficiency of resource sharing, and create an organic system for drug safety governance. Actively implement the drug safety credit supervision mechanism, formulate trial basis and public charter for illegal acts and untrustworthy acts based on judicial documents, and implement a joint credit penalty mechanism.

(3) Highlight the functional role of policy guarantees. Establish a fund guarantee system that is consistent with drug management and scientifically plan and supervise funds. Develop a dynamic fee adjustment mechanism for review and approval of enterprises, integrate review, inspection, inspection, testing, and standard management into the scope of government purchase services, optimize and adjust the expenditure system, and strengthen the purchase service mechanism. The use of special transfer payments provides a good foundation for local drug supervision.

(4) Adjust the personnel management mechanism. Reasonably arrange the number of reviewers, inspectors, testing personnel, and standard management personnel, and set up chief scientist positions to attract high-quality management talents with rich experience and understanding of domestic drug production.

(5) Strengthen responsible behavior. We should do a good job in ideological and political education for drug regulatory units, continuously improve the enthusiasm, initiative and innovation of the leadership, and actively implement the political responsibilities of drug supervision. Formulate a correct employment orientation, strictly implement a management system that combines strict management with kindness, and a combination of incentives and control, and urge the leadership to be proactive and courageous in taking on responsibilities.

Whether the body is healthy is an aspect that people pay special attention to in their daily lives, especially since medicines have become a necessity in people’s lives for a long time. Therefore, ensuring the quality and safety of drugs is an extremely important prerequisite. For companies that produce drugs, the prerequisite for obtaining economic benefits is the quality, safety and effectiveness of the drugs they produce. Failure to ensure the quality and safety of drugs will cause serious physical or mental harm to people. Strengthening drug quality control is an important task in the operation process of pharmaceutical companies. In the context of the new era, pharmaceutical companies should establish correct safety awareness and quality awareness, formulate a scientific and comprehensive quality supervision mechanism, and conduct scientific and comprehensive supervision and restraint on drug production, thereby improving drug quality and effectively safeguarding people’s health.