Summary of Quality Assurance in Pharmaceutical Factory

Summary of Quality Assurance in Pharmaceutical Factory

Summary of Quality Assurance in Pharmaceutical Factory

Time flies, and the years are like songs. In a blink of an eye, 20xx has quietly come to an end, and we are about to enter a brand-new 20xx. Looking back on 20xx, under the leadership of the chairman of the group company, our Yizheng Group has made great progress in both economic and social benefits compared with the previous year, and it is under such a good opportunity that I entered this big family. From mid-May to now, I have worked in the pill workshop for seven months. Although seven months of light and shadow can't cultivate a firm belief, I have gained a lot of care and help from my superiors and colleagues around me. Here I want to say thank you to them, and through my own efforts, my business level has been significantly improved. Therefore, I finished my work well. During this period of work, I realized that I am working happily, living happily, working hard for my life goals, and my personal thoughts are becoming more and more mature. Summarizing the past can help us explore the future better. "The road I have traveled is like iron, but now I am striding forward from the starting point." At this time, it is necessary for me to make a serious summary of my work in the past year in order to make myself do this. To a great cause. "The following is a summary of my work in 20xx.

First, improve their own quality and strive to adapt to the working environment.

After coming to work in the company, in order to meet the needs of QA work, I always put learning business knowledge in the first place, improve my special quality in management, let myself gradually become a qualified management talent, communicate with colleagues, help others, and let myself quickly integrate into the company team. On the other hand, I strictly abide by the company's rules and regulations, do not be late or leave early, and actively participate in various activities and trainings held or organized by the company and workshops. (such as GMP, enterprise management related training, Siping City Federation of Trade Unions cultural performance, etc.). ). Through GMP training, I have enriched my GMP knowledge, which is more conducive to the effective development of my own QA work.

The quality and efficiency of all work have been significantly improved.

Second, carefully monitor the production process and implement QA work.

One of the main contents of QA job responsibilities is the on-site monitoring of production process. Every morning after I come to the company, I will monitor the production process in real time according to my post in the following steps.

1. Check whether all the equipment and main entrances at the production site of each post have status labels, check whether the intermediate products stored in the intermediate station have intermediate product labels indicating the material name and flow direction, and whether the posts and equipment that are temporarily not produced have cleaning labels and are within the cleaning validity period.

2. Weighing batching post should check whether the names, specifications and weights of raw and auxiliary materials are consistent with batch production instructions, and the liquid level of weighing instrument should be zero, and recheck.

3. Medicine mixing post: Check whether the hardness, uniformity and color of the mixed pills are consistent (reproduced in www.zaIdian.cOM store).

4. Pill making and cutting: check whether the pill weight is within the internal control standard and whether the pill shape is round.

5. Drying post: whether the temperature and drying time of the fluidized bed meet the requirements, and whether the moisture and temperature meet the process requirements.

6. Coating post: check the receiving and coating materials of batch production instructions, and check the appearance, roundness, uniformity and color consistency of pellets during coating. Ensure that the appearance and weight difference of production varieties meet the company's internal control standards;

7. Aluminum-plastic packaging post: check whether the appearance of the medicine board is accurate, whether the board surface is clean, whether the joints are tight, and whether the production batch number and validity period are consistent with the batch production instructions.

8. Packaging post: Check whether the batch number, production date and expiration date of drugs are consistent with the batch packaging instructions, and conduct spot checks on the packaging site. Whether the packing quantity is accurate and the packing list is correct.

In the process of on-site supervision and inspection of each post, if any place that does not meet GMP requirements is found, the post monitor or relevant personnel will be informed in time to correct it. Report quality problems to superior leaders in time.

Situation, coordinate and solve.

Third, work closely with the technician * * * to complete the file modification and batch production record audit of workshop equipment cleaning verification. Batch production record audit is also one of my priorities. As of 20xx65438+February 65438+February 02, the batch production records of various varieties 1 17 batches have been reviewed, including filling in the customs clearance certificate. Whether the data in the reinspection record is calculated accurately, whether it is consistent with the contents of batch production instructions and packaging instructions, whether the record is complete, whether the post order is correct, and whether the material balance meets the requirements. In addition, due to the need of new GMP certification, I cooperated with technician Li Mo to complete the revision of 36 documents in two parts: equipment cleaning verification and equipment confirmation. The arrangement of verification scheme and verification report is mainly to ensure the reliability, accuracy and reproducibility of the above projects in the work process.

Fourth, cooperate with the sales department to complete the preparation and reporting of monthly sales records.

At the end of each month, according to the sales data provided by the sales department, complete the preparation of sales records and report them to the quality management department. By the end of February, 65438+,I had completed the preparation and reporting of sales records for seven months.

Five, complete the clean area temperature and humidity, dust ion detection and data statistics filing.

According to the new GMP certification requirements, the quality management department revised the new template of temperature and humidity records in clean areas. From May-65438+February-* * seven months' work, such as temperature and humidity, dust ion records, data statistics, etc., combined with the records of settling bacteria provided by the central laboratory, submitted to the quality management department for archiving.

Six, according to the scheduling with the central laboratory to complete the sampling work in the production process.

As of February 23rd, 65,438 and * * 237 samples of various kinds of intermediate products, products to be packaged and finished products have been completed. After the samples pass the inspection, the central laboratory will provide the inspection report. Sixth, other aspects.

According to the arrangement of workshop leaders, complete other temporary work arranged by the director. The main performance is: temporary work, such as compiling the internal situation description and personnel statistics of the workshop.

The above six aspects are the contents of my work in the second half of 20xx. Through continuous study and exploration, I have seen my own advantages, I am hard-working, willing to work, and not afraid of hardship. Positive working attitude and strong pressure resistance are my motivation for this job. Of course, I also have my shortcomings. This can be summarized as follows:

1. Insufficient communication with workshop leaders, sometimes unable to understand the real wishes expressed by the factory director, leading to thankless work.

2. Management ability needs to be strengthened, because my previous work rarely involved management matters, so after coming to the company, I feel that my management ability has a relatively large room for improvement. As the teacher said, management is an art, which encourages employees actively, trusts employees and lets them go. The purpose is to give full play to the subjective initiative of the squad leaders and employees in each position, so as to perform their duties and make fewer mistakes in dealing with problems.

3. Insufficient workflow. Sometimes I don't know what to do at work, but I still arrange a workshop post to do it. For example, fill in personal work records. On the other hand, you will have endless work in your hand. Can't achieve the result you want. I think we should learn from Secretary Jiu Duan. The year before last, I had the honor to participate in an executive training, during which I commented on the highest realm of Jiu Duan's secretary. At work, I need to be active all the time, standardize and standardize the seemingly disorderly work, and complete every link according to the standardized process every day in order to achieve satisfactory results for myself and my superiors.

If you don't accumulate steps, you will be thousands of miles away; If you don't accumulate steps, you can't make a river into a sea. Summing up the past is to look forward to the future better. In the new year, I will redouble my efforts to learn business knowledge, production technology, improve management level, and gradually move towards compound talents. The following is my work plan for 20xx.

1. Improve business level and management ability.

In 20xx, I will focus on improving my ability in two aspects, deeply study the production technology of various varieties, go to the workshop more often at ordinary times and communicate with front-line operators. Pay attention to the improvement of management ability, learn the management mode of superior leaders, dare to manage and dare to make decisions. Gradually strengthen their own management level.

2. Strengthen the monitoring of the production process, and earnestly complete all the work assigned by the leaders.

Further strengthen the monitoring in the production process, be brave in finding and solving problems, don't rely on superiors for everything, and conscientiously complete all the work arranged by the director without slacking off or delaying.

3. Follow up the inquiry of product inspection results in time.

After the workshop scheduling, improve the sampling speed and efficiency, follow up the test results in time, and make records to ensure the orderly operation of the workshop production process.

4. Strengthen the audit of batch production records and cooperate with technicians to complete the modification of documents in the workshop and other related work.

In the audit of batch production records, check the relevant data with the batch production scheduling records of corresponding varieties to ensure accuracy, and cooperate with technicians to complete the revision and filing of documents issued by workshops and superiors. (such as revision and filing of quality standards and process regulations)

The above part is my work summary during this period and my work plan for next year. Under the new historical situation, technology and quality are the soul of sustainable development of enterprises, technology serves production and quality controls product quality. Coming to Yizheng is both an opportunity and a challenge for me. Society is always progressing, and economy is always advancing. As the old saying goes: "With copper as a mirror, you can dress your clothes;" Taking history as a mirror, we can know the rise and fall; Take people as a mirror, you can know the gains and losses. "At 20xx, I will make due contributions to the company with a more active working attitude. I can also make my abilities in all aspects move towards higher goals.

Summary of Quality Assurance in Pharmaceutical Factory (2)

Friction is common in pharmaceutical factories, QA and workshops. Because QA and workshop personnel stand in different positions, QA pays more attention to quality, while workshop pays more attention to output, which leads to differences. Most of the time, the contradictions are only small differences, and if this contradiction cannot be solved, it will accumulate deeper and deeper. Over time, QA will feel that the work pressure is great and the workshop itself does not understand it. When it feels that QA has nothing to criticize, it will not help. Gradually, the workshop can't help.

So how should QA do a good job? I personally summed up the following points:

1, excellent basic skills.

The basic skills here refer to QA's business ability, quality knowledge, laboratory tests, technological procedures, operating procedures and equipment, which is also the legendary "man-machine material method ring". You must understand and master it. Many people say that you should go to craftsmen and chemists first, and then do QA. That is the qualified QA. Why, because others can't fool you, you know everything and others won't laugh at you. On the contrary, he will respect you and ask you questions, and it will be much easier for you to manage him.

2. Do a good job in interpersonal relationships.

Interpersonal relationship is very important, and so is QA. It is necessary to have principles and pay attention to methods, so as to get twice the result with half the effort. I think as a QA, he should have a big heart and the magnanimity of "the prime minister can punt in his stomach", and there are contradictions in his work. QA should look for opportunities to reconcile with the parties concerned, explain to the workshop staff in a supercilious tone why this happened at that time, and strive to reach an understanding, so as to communicate well in future work. QA and workshop are usually unsociable, like two gangs. Because of our different positions, it is normal to be divided into two factions, but as a QA, if we want to carry out our work better, we must have a good relationship with the workshop staff, help them more, communicate more, and avoid quality conflicts, so that our work will be much smoother.

In case of quality problems, you should tell him what to do and why to do it. If the employee has no resistance to you, I think he is willing to cooperate with you. If your usual relationship is stiff, then your work will not go smoothly.

3, serious, rigorous and careful.

If you say that you just graduated, your basic skills are almost zero; You said I was not good at dealing with people and would not be involved in the workshop. Then you must first do these three things, that is, be serious, rigorous and careful. After work, QA can be casual, it doesn't matter whether you laugh or not, and I think you should keep an optimistic and relaxed attitude at ordinary times, because QA is a stressful job, so you should decompress yourself at ordinary times. But once you enter the work, you must maintain a serious and rigorous work attitude, which is the minimum requirement. These three points are reflected in the following things: whether to be unsmiling when monitoring the production of the workshop, and strictly require the workshop staff to operate according to the operating rules, rather than tolerate them; When cleaning up the site, whether it is meticulous and serious, leaving no dead ends, not "almost";

When filling in records and signatures, are you careless and often make mistakes (in this case, the employee's view of you is: why do you still review my records when the records are written like this); When on-site inspection or audit records, problems that should be found (such as obvious equipment cleanliness, empty records, etc.) can be found. ).。 . If you have done all the above similar things well, congratulations, you have the potential to become an excellent QA.

4. Establish prestige.

As QA, we are the quality barrier of the workshop. If we don't adhere to the principle and give the green light to some behaviors in the workshop, then we are irresponsible. You are sorry for the position of QA. And when you stick to your principles many times, you will find that you have become authoritative. You are no longer a dispensable person in the workshop, but an "important person" who adheres to principles and controls quality. For example, there is a QA in a workshop, and every day, the scene is monitored (early shift) to sleep, and the clearance is not serious. She thinks she has a good relationship with the workshop, but the workshop staff all know that she is an unqualified QA and muddle along every day. After a while, she had to leave her job. So the quality department took the blame for "muddling along" for a while. Another QA found that when monitoring in the workshop, the supervisor did not wear gloves to grasp the "soft material". He stopped it, but the director didn't listen and reported it. The director was criticized at the meeting. A few years later, this QA was promoted to QA supervisor, and now he is the vice minister of quality department. Therefore, I believe that adhering to principles is also adhering to oneself.

5.QA is a team.

QA must be a team, not just a gang of several people. QA's work in the workshop is very stressful, so we must "hold together", stand together when encountering quality problems, and the standards should be consistent in daily monitoring. For example, it is necessary to formulate unified on-site control and inspection standards for sorting in advance and implement them conscientiously. After a long time, the workshop will get used to this standard and what we want to ask will be achieved.

6.QA needs the support of leaders.

QA has an awkward position in the workshop, and its management power is not as big as that of the workshop director, so it has no real power. Technical ability can't catch up with craftsmen, which is one of the reasons why QA has no position in the workshop. Therefore, QA first needs the support of leaders and defines the positioning of QA. QA is not only a "man walking around the scene", but also a "hygienist-inspector" and a "random signer", and needs to be an "arbitrator". At this time, leaders need to give QA more rights. For example, some abnormal situations will happen in the workshop, and how to deal with them is basically the leader's decision. I know that a pharmaceutical factory has handed over the handling of common anomalies to QA, and the anomalies must be reported to QA for handling (except serious anomalies), so that QA has a certain right to speak. Leaders can also hand over the ruling power of other matters to QA, so I think QA will have some position in the workshop.

7. Change the quality consciousness of the workshop director.

This is a killer. Everyone knows that the workshop director is out-and-out in the workshop If you have enough positive energy to change the quality consciousness of the workshop director, then your work will be like a duck to water. This thing is possible, because I personally experienced that when a director first came, he treated the quality as lukewarm as other directors, but after the "influence" of a QA supervisor, it changed a lot. Whenever there is a contradiction between QA and the team leader or employee, for whatever reason, scold the workshop first and then ask the reason. QA is also very supportive in daily work. Of course, this also has a lot to do with the efforts of the leaders of the quality department. Alternatively, QA can often train workshop staff to improve their quality awareness and establish a "total quality awareness". Let QA and employees establish the same quality objectives. If the goals are the same, the differences will be reduced.

8. Communication skills are very important.

QA needs to communicate with many people at work, so communication ability is very important. The same question, different people will get different results. Therefore, it is necessary to cultivate your communication skills, which can help you get the information you want and help you get along well with the workshop staff.

To sum up, I personally think that a serious and rigorous work attitude is the premise of QA, basic skills are your treasure house (take out useful things at any time), communication skills are your weapon, and quality department is your guarantee. With these, I think the workshop should have a foothold for you, and you can do QA better!

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