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GMP training experience 1
Since the publication of good manufacturing practice (20 10 Revision) in February this year, although I have taught myself the new version of GMP and participated in the new version of GMP training organized by the provincial bureau in May, I have a general impression and understanding of the new version of GMP, but I still don't know much about some specific terms of the new version of GMP, and even have some misunderstandings. By participating in the new GMP publicity training course organized by the Advanced Training Institute of the US Food and Drug Administration, I have a deeper understanding and understanding of the new GMP, and I have gained a lot in this training course. There are mainly the following aspects of learning experience:
First, look at norms from a systematic perspective and learn the concept of norms in a systematic way.
In the process of learning and implementing GMP version 98, it is customary to understand GMP terms in isolation, dispersion and static state, and the usual management is also carried out in isolation against GMP terms and GMP certification inspection items and evaluation standards version 08. In the process of participating in the new GMP training, all teachers are instilling a systematic, holistic and continuous concept of learning and implementing GMP.
The second is to cultivate a new version of GMP software, which further strengthens the concept of software requirements.
The new GMP puts forward requirements for the design and layout of factory facilities in production area, storage area, quality control area and auxiliary area respectively, and also makes specific provisions on the design and installation, maintenance and repair, use, cleaning, status identification and calibration of equipment.
The requirements of the new GMP for software have been raised to a very high level. Emphasize the consistency, continuity and stability of GMP implementation. The revised GMP of 20 10 runs through the specific requirements of confirmation and verification, among which the first paragraph of article 183 clearly requires that confirmation and verification should have corresponding operating procedures, and its process and results should be recorded.
Third, the concept of changing from conformity quality to applicability quality has been deepened, and it is more deeply recognized that drugs are designed and produced rather than tested, and the test is unreliable.
The 98 version of GMP is about conformity, and the 10 version of GMP is about applicability. The 10 version contains many principled things. Each unit can use scientific means, according to the characteristics of its own products, focusing on product quality, and implement GMP in its own way, which improves its applicability. A lot of space has been added, and the new version of GMP is more instructive, inspective and operable, which is more in line with the regulatory requirements of product applicability.
Fourth, further understand the importance of quality management system.
The purpose of establishing quality management system is to achieve quality management objectives and effectively carry out quality management activities. It is a complete system composed of organizations, responsibilities, procedures, activities and resources. The new version of drug GMP has increased the requirements for enterprises to establish a quality management system in the "General Provisions" to ensure the effective implementation of drug GMP.
5. Establish the concept of quality risk management.
Quality risk management is a brand-new concept advocated and implemented by FDA and EU. The new version of drug GMP introduced the concept of quality risk management, and correspondingly added a series of new systems, such as supplier audit and approval, change control, deviation management, OOS investigation, corrective and preventive measures (CAPA), continuous stability inspection plan, and product quality traceability analysis. These systems manage and control the risks that may occur in each link from the aspects of raw and auxiliary materials procurement, production process changes, deviation handling in operation, investigation and correction of found problems, and continuous monitoring of drug quality after listing, so as to urge production enterprises to establish corresponding systems, find unsafe factors affecting drug quality in time, and take the initiative to prevent quality accidents.
In a word, participating in this GMP training class has increased our knowledge, broadened our horizons, inspired our thinking of solving problems and deepened our understanding of terms. However, due to the short study time, comprehensive mastery and refinement need further study and consolidation. This research lacks communication with teachers.
Communication, there is still something I don't understand. Through study, we learn principles, methods and ideas. For the application and implementation of GMP, we should also adopt a comprehensive and scientific method and adopt unique forms according to the characteristics of different products. This training is propaganda training, which is at the macro level. Due to the limited level, learning is superficial. Please criticize and correct me.
GMP training experience II
One year after I left college, I was lucky enough to pass the exam and become a member of the teaching staff, and I was about to start a new journey in my life.
Although I have a year's work experience, it is extremely small and far from enough for the great education cause.
The Education Bureau is very considerate. In order to make our new teacher adapt to the education work as soon as possible, we have conducted special training. During the training, several principals gave us wonderful lectures, which were rich in content, including how new teachers should strive to grow up, what educational concepts new teachers should establish to take the first step in the workplace, how to do a good job as a class teacher, and teachers' career planning and professional growth.
After several days of training, I was deeply touched and gained a lot, which also gave me a deeper understanding and further planning of the future teacher road.
What impressed me most during the training was how to plan my new teaching career and keep my enthusiasm for work forever.
I think we should have a clear goal first.
My goal is to adapt for one year, be competent for two years and explore my teaching style for three years.
During the training, President Meng said that the new teacher should find his own master before taking up his post, so I set the first year as the stage of learning imitation from the teacher.
My teaching ideas and methods are very lacking. I need to listen more, read more, consult more, and even talk more, so as to exercise myself a little, integrate into teaching as soon as possible and adapt to teaching.
After the "adaptation period", you need to be "competent" as soon as possible, that is, constantly enrich yourself. First of all, you should improve your professional teaching skills, including the general basic skills of teachers, that is, "three strokes and one painting", the skilled application of multimedia teaching, the basic skills of classroom teaching, that is, dealing with the key points and difficulties of teaching, and having your own set of methods to manage students.
During this period, the most important thing is to keep learning, master new teaching concepts and methods, and apply them to practical teaching in combination with the characteristics of their own students, so as to strive for early competence in teaching.
The symbol of a teacher's success is his own teaching style, so my goal for senior three is to explore his own teaching style, skillfully use various teaching methods, complete the prescribed teaching tasks, achieve excellent teaching results, and have high prestige among students. This goal is very arduous, but I will work hard in this direction, work hard and put it into practice!
The front is just a short-term career plan for myself. For the long road of teachers in the future, I have a further ideal, that is, to be a teacher who makes students willing to talk to you.
He is willing to tell you that no matter he has difficulties in study or life, you should help him. He has something happy and likes to share it with you. I hope that what I sow in children's hearts is not only the seeds of knowledge, but also sunshine and love for life.
Maybe this ideal is difficult to realize, but I will always work hard for it and pursue my life.
GMP training experience 3
These five days of GMP training have opened my eyes and learned a lot about pharmacy! Let me know the importance of drug safety! Let me feel that the development of medicine is bright!
The implementation of GMP 20 10 version is both an opportunity and a challenge for pharmaceutical enterprises. The new GMP terms are more specific, instructive and operable; Ensure the safety, stability and uniformity of drug quality.
The implementation of the new GMP has put forward higher requirements for our pharmaceutical production in the future, such as: documents, records, forms, deviations, changes, verification, inspection process, inspection results, raw materials, reference standards, reagents, test solutions, staffing, post responsibilities and so on. What to do, how to do it and how to do it well to meet the requirements of GMP are all worthy of our in-depth thinking.
1. The new version of GMP introduces the concept of risk management and adds a series of new systems accordingly. Especially after learning GMP, I feel that there are still many places to be improved.
2. Continuous stability inspection is the continuous monitoring of the quality of drugs after listing, and it is an important link of quality risk management, actively preventing the occurrence of quality accidents and ensuring the quality of finished products and listed drugs to the maximum extent.
3.GMP puts forward detailed management requirements for the management of reagents, test solutions and culture media. The quality was not checked at the time of purchase, and the problems were solved when they were found in use. The management document is not detailed, and there is no requirement to record the bottle opening date, set the service life and increase the batch number of the prepared reagent. These are all places that we need to pay attention to in the future. The management of records begins with records.
3. Seriously study GMP, and truly integrate the simple ideas; If samples are left, why the samples of raw and auxiliary materials are enough for identification, etc. Understand the meaning of every sentence deeply and put it into practice. Compare the contents of old and new GMP
First, some hardware requirements have been improved.
First, the cleanliness requirements of the production environment of sterile preparations were adjusted. The main differences between the new version and the 98 version of GMP are: the hardware of aseptic preparation has been greatly improved, and the aseptic and purification requirements of production technology have been emphasized more; In soft management, personnel management, deviation handling, document management, quality control, quality assurance and quality review have all been greatly improved.
The second is to increase the requirements for equipment and facilities.
The design and layout requirements of factory facilities are put forward for production area, storage area, quality control area and auxiliary area respectively, and specific provisions are made for equipment design and installation, maintenance and repair, use, cleaning, state identification and calibration.
Second, strengthen management requirements.
First of all, the requirements for personnel have increased.
In the part of organization and personnel, the quality authorized person is clearly listed as the key personnel of pharmaceutical production enterprises with the person in charge of the enterprise, the person in charge of production management and the person in charge of quality management, and the qualification requirements for key personnel are improved from the aspects of academic qualifications, technical titles and work experience. The newly revised drug GMP put forward the concept of quality authorized person for the first time, and incorporated the quality authorized person into the key personnel of drug production enterprises. All drugs in the enterprise need to be approved before leaving the factory. This person is the first person responsible for the quality of the enterprise and should be filed with the Food and Drug Administration. The quality authorizer has strict qualification requirements.
The second is to explicitly require enterprises to establish a drug quality management system.
The new edition puts forward a separate chapter on quality management, and enterprises must establish a comprehensive quality assurance system. The new GMP has raised the quality management to a higher level. The whole pharmaceutical enterprise, from top leaders to employees, should be responsible for quality and make its own management plan. The new version of drug GMP has increased the requirements for enterprises to establish a quality management system in the "General Provisions" to ensure the effective implementation of drug GMP.
The third is to refine the requirements of document management such as operating procedures and production records.
In terms of document management, the new version of GMP has greatly improved the content requirements of document management and increased the scope of document management, including all quality standards, production prescriptions and process regulations, and records and reports related to product quality. It is clearly pointed out that all kinds of records and statements formed according to various standards or regulations are documents and must be managed systematically, and the concept of batch files is put forward. Each batch of drugs should have batch files, including batch production records, batch packaging records, batch inspection records, drug release audit records, batch sales records and other records and documents related to batch products. Batch documents shall be kept and filed by the quality management department. In this way, the record management of the whole drug production quality has formed a complete system, which is convenient for the traceability and improvement of product quality.
Thirdly, around risk management, a series of new chapters on system quality control and quality assurance, change control and deviation handling have been added, and this time, corrective and preventive measures and product quality retrospective analysis have been added. These aspects intersect to say one word: quality risk management. The purpose of corrective and preventive measures is to systematically summarize, analyze and summarize the factors and existing problems involved in all aspects of product quality, and take effective and feasible measures to solve the problems and ensure the quality of drugs.
The process of drug production quality management is the implementation and embodiment of registration approval requirements. The new GMP emphasizes the consistency between production requirements and registration approval requirements in many chapters.
The chapter on product distribution and recall, originally called recall, is now called recall, which emphasizes the management of enterprise sales, and at the same time strengthens the connection with the Measures for the Administration of Drug Recall, stipulates that enterprises should recall listed drugs with potential safety hazards, and at the same time refines the management regulations of recall, requiring enterprises to establish a product recall system, designate a person to be responsible for implementing recall and coordinating related work, and formulate written recall handling operating procedures.
The core of GMP is to ensure the constant quality of drugs. The new GMP strengthens the requirements and management of people and software, focusing on ensuring standardized production processes. In the process of GMP implementation and transformation, software upgrade is the lowest cost and the highest efficiency. A set of systematic and scientific software can even make up for the lack of hardware and personnel quality. A good software system should have the following six characteristics: systematicness, integrity, accuracy, consistency, traceability and stability. This requires enterprises to mobilize employees to modify, integrate and transform the existing software from every detail and link according to the requirements of the new GMP, so as to effectively improve the software level and operational ability of enterprises.
What impressed me most during the training was the morning of the third day of training. The teacher explained many requirements to us in the training workshop. Later, we visited the training workshop. The teacher told us to wear white coats to the training workshop. The teacher told us the correct procedure for entering the workshop. In order to keep the workshop clean and tidy and form a habit, it is in accordance with GMP requirements! Take off your personal shoes, put them in the shoe cabinet, turn around, put on clean work shoes, enter the first dressing room, take off your coat, wash your hands and dry them, enter the second dressing room, put on a work hat, cover your hair and ears, put on a mask, cover your nose and mouth, put on clean clothes, zip up and put on clean pants, with the waistband on the outside and side of your coat, so that you can enter the production workshop. It is said that in order to prevent microbial growth, even the air is filtered, and the flow of people and materials is separated. However, on the other hand, we watched the preparation machines of various preparations, and the teacher also explained to us that the medicines we usually take are made by these machines, which makes us feast our eyes.
The rest of the training time, we are learning theoretical knowledge and going to the computer room to operate GMP training software. My biggest feeling is that we use our beloved qualities. Do a line and love a line, do quality and love quality; Only in this way can we really do it well. Constantly break through yourself in the field of quality and be an enterprising person. Only by establishing a complete quality management system for pharmaceutical production and strictly implementing GMP standards can pharmaceutical production enterprises have a good idea of their own drugs, and each batch of drugs can be put on the market to serve the broad masses of the people. Only by implementing GMP can pharmaceutical production enterprises achieve "full process and all-round participation" and make the quality of drugs they produce "stable, reliable and high quality".
How time flies! This is the end of the training. This training made me realize that the development of medicine is bright, and I found that there is a directional road ahead, which is the stage for success! !
GMP training experience 4
In order to consolidate the results of classroom teaching and master the course knowledge, the college organized this pharmaceutical practice activity for us. This summer vacation, a group of 19 college students came to Nanjing Rishengchang Biotechnology Co., Ltd. for a four-day internship. Under the guidance of the teacher, we have learned a lot of knowledge that is not in the textbook through on-the-spot investigation, serious study and watching the production process.
First, the internship company profile
On July 12, we came to Nanjing Rishengchang Biotechnology Co., Ltd. for production practice. Through the internship mobilization meeting, we have a deeper understanding of this company.
Rishengchang Pharmaceutical 1999 was established in Taiyuan, Shanxi Province in August, and its headquarters moved to Nanjing in 2003. At present, it is a large pharmaceutical group with 2 GMP production bases, 5 marketing companies and 1 drug research center. Rishengchang Company owns 10 GMP workshop, which includes powder, powder, premix, granule (containing Chinese medicine extract), oral liquid (containing Chinese medicine extract), small-volume injection, large-volume injection, disinfectant (solid and liquid), pesticide (solid and liquid), Chinese medicine extract (licorice fluid extract), additive premixed feed, etc.
The company has successively developed well-known products in the market such as "Lan Qi Capsule Sick Drink", "Linsan Mixture", "Substituting Sulfonic Acid" and "Clearing Palace to Promote Pregnancy". Among them, Lan Qi Capsule Disease Drink, Qinggong Pregnancy-promoting Treasure and other achievements have won national invention patents. At present, the company is still in the same industry position in the fields of high-concentration compound sulfadiazine solution technology, livestock infertility technology, compound high-concentration multi-dimensional solution, food attraction and growth promotion technology, and biological mosquito control technology.
Second, the internship harvest
1.GMP workshop visit
12 in the afternoon, we visited the solid preparation workshop, and the experience of the production department told us the classification of preparations: granules, tablets and capsules. The production process of granules is: peeling → crushing → mixing → full mixing → inner packaging → outer packaging. The production process of tablets: tabletting → inner packaging → outer packaging, and the packaging material is laminated film. Its equipment mainly includes tablet press, full mixer and granulator. Later, I visited the process of water purification in the liquid production workshop: general water → mechanical filtration → quartzite filtration → mechanical filtration → ultraviolet sterilization, followed by Shi Ying filter → activated carbon filter → mechanical filtration. The temperature in the clean area is generally 18-26 degrees Celsius. The humidity is 45%-60%.
2. Workshop production practice
13, we started our formal internship life. We 19 people are divided into two groups, namely powder workshop and oral liquid workshop. In the first week, our group was divided into oral liquid workshops. We didn't participate in the preparation process of oral liquid, but did the final filling and packaging work. Although it is only the simplest packaging and filling, it is not as easy as imagined. At first, we were slow to label it.
Later, I gradually became familiar with the method of pasting, which was much faster, but I still often couldn't paste the label well. Later, after repeated work and careful thinking, we can finally paste the label quickly and well. After labeling, you should put the packaged bottles into special foam boxes, then put them into boxes one by one, and finally put them into boxes labeled uniformly. It was my first contact with packaged things, and it was very fresh and interesting, so I worked hard and didn't feel tired at all. But after working for a long time, I felt that the work was boring, so I really admired the employees who worked in this workshop at that time. Some of them have worked here for three or four years.
In the next few days, we went outside the workshop to help produce pesticides. Similarly, we are still filling, sealing and labeling. Although the sealing is made by machine, some bottles can't be sealed, so someone must pick out those unsealed bottles at any time. Moreover, we found that before sealing, the caps of some large-capacity bottles were not tightly screwed by hand, and special wrenches were needed to screw them, so the chances of sealing were much greater when sealing. In fact, a seemingly simple job like this is not so easy to do, and it needs constant observation and discovery of tricks to do it well.
The next week, because we changed jobs, our group went to the powder shop. In the powder workshop, we have done the work of measurement and packaging. When I first started to pack powder and bags, I didn't know much about the measured amount, so I always packed too much or too little. This brings trouble to weighing students and slows down the production progress. Later, I gradually got the concept of measurement, how much medicine should be put into the bag when weighing, and then the progress was accelerated. After that, we put the medicine bags in small packages into cartons, weigh them, and finally seal them with a packaging machine. During this period, we also used the new inkjet printer in the factory to inkjet the sealed medicine bottles, which gave us a deeper understanding of the whole packaging process.
3. Internship experience
Although it is only a short two-week social practice, it has benefited me a lot. Go out of the classroom and practice. Experience and understand what you have learned in practice textbooks by yourself. In this short ten-day internship, we learned professional knowledge in pharmacy, broadened our horizons, and more importantly, our understanding of the company and our own development was quite shocking. It is no exaggeration to say that this practice has changed some completely wrong views in the past.
GMP training experience 5
On the first day of entering the factory, all the fresh graduates who participated in the internship were trained in the pharmaceutical factory in the conference room. First, let's understand the factory layout and workshop layout of the pharmaceutical factory, be familiar with the relevant principles, and introduce the drugs produced in each workshop and the workshop leaders to us. Then the managers of each department explained the workshop technology, safety, fire protection knowledge and corporate culture to us, which made us familiar with the pharmaceutical production process (from raw materials to finished products), understood the material flow of each workshop, strengthened the study of GMP knowledge and safety knowledge, and combined theory with practice. After we trained this knowledge, we were assigned to various workshops for a long time and started workshop practice.
I was assigned to a new oral preparation workshop, with more than 20 fresh graduates. This workshop was newly built in _ _ _. When we first arrived at the workshop, our director said that we should work together and the workshop will participate in GMP certification in February. Then tell us about the drugs mainly produced in the workshop. This workshop mainly produces tablets, capsules and granules. The main products are fluconazole tablets, artificial bezoar metronidazole capsules, Yinhuang capsules, metronidazole fenbufen capsules, Shilintong granules and Yiqing granules. The director assigned us a post. At first, I was assigned to the tabletting post and learned a lot of tabletting machines and tabletting techniques from the tabletting master. It is found that such a small flat plate needs so many technological processes to make it successfully. Later, the director took a new post and I was assigned to packaging. Although I don't need technological knowledge such as pressing tablets in packaging, I am happy to learn in packaging. Each of our freshmen has a good relationship with the packaging master. In this way, through our joint efforts, we passed the GMP certification in February. Each of our freshmen is sincerely happy.
During several months of internship, each of our freshmen has their own work card like a real employee and feels that they are no longer students. They go to work like office workers, get up at 7 o'clock every morning, change their work clothes in the workshop at 7: 50 on time and start work. During the internship, I will abide by the company's various systems, do not sleep, do not entrust posts, do not rob posts, have no major accidents, and learn from experienced teachers with an open mind. Earnestly complete the tasks assigned by the leaders, and apply the professional knowledge learned in the university to the work, expand their professional knowledge and post safety knowledge after work, and make themselves more competitive in the work.
Time flies, and our six-month internship is about to expire. I think internship is a very important experience for a newly graduated college student. Internship is a platform for us to leave school and get in touch with society, and a window for us to truly feel the society. This half-year internship in a limited company has made me learn a lot, which is of great significance to me. It helped me to improve my communication and interpersonal skills and experience the life of office workers in advance. During my internship, I enriched my professional knowledge, accumulated work experience, laid a foundation for future work, found my own shortcomings, made up for them as soon as possible, and enhanced my ability to adapt to society. Let me have a deeper understanding of society and integrate into society more conveniently. Not only did I have a new understanding of pharmaceutical technology in theory, but also improved my practical ability. Really apply what you have learned, learn a lot of things that books can't learn, effectively exercise yourself, broaden your horizons, broaden your horizons. Internship is an attempt to apply the theoretical knowledge we have learned in school to practice, and it is the first step for us to go to society. Let me know that my knowledge is too superficial and my professional knowledge lacks practical application. Let me know more that I need to learn too much, and let me know that I must know more to have a place in today's competitive society.
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