The pharmaceutical production GMP virtual training simulation system is for pharmacy-related professional practice teaching needs, the development of a practical training simulation software. The following is what I have organized for you about gmp practical training experience 5_examples of practical training experience, I hope it will be helpful to you. Welcome to read reference learning!

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Training experience dare to ask a selection of 5

The first year of the practical training experience 3

Summary of internships and experience

On the financial practical training experience 5

5 college students internship experience

GMP practical training experience 1

Since the drug production quality management specification (2010 revision) in February this year since the release of my self-study of the new version of the GMP, but also participated in the May Provincial Bureau of the new version of the GMP training, the new version of the GMP have a general impression and and I have a general impression of the new GMP and a general understanding of the new GMP, but some specific provisions of the new GMP understanding is not very deep, and even there is a misunderstanding of the place. I through the State Food and Drug Administration Advanced Training Institute organized by the new version of the GMP awareness training course, the new version of the GMP has a more profound knowledge and understanding of the new version of the GMP, in this training course is very fruitful. There are mainly the following aspects of the learning experience experience:

First, with a systematic vision of the norms, with a systematic approach to learning the concept of norms.

In the 98 version of the GMP learning and implementation of the process, accustomed to isolate, decentralized, static understanding of the GMP provisions in the usual management is also isolated against the GMP provisions and 08 version of the GMP certification inspection projects and assessment standards. In the process of participating in the new version of GMP training teachers are instilling a systematic, holistic, continuous learning and implementation of the concept of GMP.

Second, the training of the new version of the GMP software and hardware, to further strengthen the concept of software requirements.

The new version of the GMP plant facilities are divided into production areas, storage areas, quality control areas and auxiliary areas, respectively, to put forward the design and layout of the requirements of the design and installation of equipment, maintenance and repair, the use of cleanliness and status of the labeling, calibration, and so on, several aspects of the specific provisions have also been made.

The new version of GMP requirements for software has been raised to a very high level. Emphasized the consistency, continuity and stability in the implementation of GMP. 2010 revised version of the GMP throughout the confirmation and validation of specific requirements, which Article 183, paragraph 1, clearly requires that the confirmation and validation of the corresponding operating procedures, the process and results should be recorded.

Third, deepen the concept of change from conformity quality to applicability quality, a deeper understanding of the drug is designed and produced rather than tested, the test is not reliable.

The 98th edition of GMP is about compliance, and the 10th edition of GMP is about applicability. 10th edition has a large number of principles, the units can use scientific means, according to the characteristics of their own products, product quality as the center of the implementation of the GMP in their own way to improve the applicability. Increased a lot of space, the new version of the GMP is more instructive, inspection, operability, more in line with the regulatory requirements of the applicability of the product.

Fourth, further understanding of the importance of the quality management system.

Quality management system is to achieve quality management objectives, effective quality management activities and the establishment of a complete system consisting of organizational structure, responsibilities, procedures, activities and resources. The new version of the drug GMP in the "General Provisions" added to the enterprise to establish a quality management system requirements to ensure the effective implementation of the drug GMP.

Fifth, the establishment of the concept of quality risk management.

Quality risk management is the U.S. FDA and the European Union are promoting and implementing a new concept, the new version of the pharmaceutical GMP introduced the concept of quality risk management, and accordingly added a series of new systems, such as: supplier audits and approvals, change control, deviation management, overruns (OOS) investigations, corrective and preventive measures (CAPA), the continuous stability of the inspection program, product quality review analysis. Review and analysis of product quality, etc. These systems are respectively from the procurement of raw and auxiliary materials, changes in the production process, the operation of the deviation processing, the investigation and correction of the problems found, the continuous monitoring of the quality of the drugs after the market, etc., to manage and control the risks that may arise in each link, prompting manufacturers to establish a corresponding system, timely detection of insecurity affecting the quality of the drugs, and take the initiative to prevent the occurrence of quality accidents.

In short, participating in this GMP training course allows us to increase our knowledge, broaden our horizons, inspire our problem-solving ideas, and deepen our understanding of the provisions. However, due to the short learning time, comprehensive mastery and refinement still need further study and consolidation. This study lacks communication with the teacher

Exchange, still do not understand the place. Through the study, learned is the principle, methods and ideas, for the use and implementation of GMP, but also the use of comprehensive scientific methods, according to the characteristics of different products, to take a unique form. The training is the implementation of training, macro-conceptual level, due to the level of limitations, learning superficial, please criticize and correct.

GMP practical training experience 2

Out of the university door after a year, I was fortunate to pass the examination, to become a member of the team of teachers, is about to start a new journey in my life.

Although there has been a year of work experience, but this for the great cause of education, is extremely small, is far from enough.

The Education Bureau is very considerate, in order to let our new teachers as soon as possible to adapt to the work of education, specially for us to carry out training, training in several principals for us to do a wonderful lecture, lectures are very rich in content, including new teachers how to go to the efforts of the growth of the new teacher to set up how the concept of education to go to the first step of the career, how to do a good job of classroom work, as well as the teacher's career planning and professional growth.

A few days of training down, I feel very deep, harvest a lot, but also let themselves on the road to the future of the teacher has a deeper understanding and more far-reaching plans.

What I felt most y during the training was how to plan my career as a new teacher, so that I can always keep my passion for work.

I think the first thing is to have a clear goal.

My goal is to adapt in one year, become competent in two years, and explore my teaching style in three years.

In the training, Mr. Meng, the principal, talked about the need for new teachers to find a master of their own before they start work, so I set my first year as a stage of learning from and imitating a master.

Their own teaching concepts and teaching methods are very lack of, need to listen more, see more, ask for advice, and more to speak, in order to exercise themselves a little bit, so that they can quickly integrate into the teaching work, adapt to the teaching.

In their own through the "adaptation stage", we need to "competent" as soon as possible, which will continue to enrich themselves, first of all, is to improve their professional teaching skills, including the general basic skills of the teacher is also the The first is to improve their professional teaching skills, including the teacher's general basic skills, that is, "three strokes and one stroke", the skilled application of multimedia teaching, and the basic skills of classroom teaching, that is, to deal with the key points of teaching and learning, as well as a set of their own management of the student's method.

The most important thing during this period is to keep learning, to master new teaching concepts and teaching methods, and to be able to combine the characteristics of their own students, apply them to actual teaching, and strive to be competent in teaching as soon as possible.

A teacher's success is marked by a set of their own teaching style, so I set the goal of the third year, is to explore their own teaching style, to be able to skillfully use a variety of teaching methods, to be able to complete the required teaching tasks, to achieve excellent teaching results, in the students have a high degree of prestige, the goal is very difficult, but I will strive to go in this direction to develop, to try and put into action! I will try to develop in this direction, to work hard, and put into practical action!

The front is just a short career planning, for the long road of teachers, I also have a more distant ideal, is to do a student willing to make friends with you as a teacher.

Whether he has difficulties in learning or life, are willing to talk to you to let you help him; he has happy things also like to share with you, I hope that I am in the hearts of children not only is the seed of knowledge, there is also sunshine, and the love of life.

Perhaps this ideal is difficult to realize, but I will always strive for it, a lifetime to pursue

GMP training experience 3

The maintenance of the five days of GMP training, so that I have opened my eyes to understand a lot of knowledge of pharmaceuticals! Let me know the importance of drug safety! Let me think that the development of the pharmaceutical industry is a bright future!

2010 version of the implementation of GMP, the pharmaceutical companies are opportunities and challenges. The new GMP provisions are more specific, instructive and operable; ensure the safety, stability and uniformity of drug quality.

The implementation of the new version of GMP for our future work in the production of drugs put forward higher requirements, such as: documents, records, forms, deviations, changes, verification, testing process, test results, raw materials, controls, standard reagents, reagents, reagents, staffing, job responsibilities, and so on in the end how to do what, how to do, how to do a good job more in line with the GMP requirements, these are worth thinking about. It is worthwhile for us to think y.

1, the new version of GMP in the introduction of the concept of risk management, and accordingly added a series of new systems, especially after studying the GMP, the feeling that there is still a need to improve many places.

2. Continuous stability inspection is a continuous monitoring of the quality of drugs after listing, which is an important part of quality risk management, proactively preventing the occurrence of quality accidents, in order to maximize the quality of finished products and listed drugs.

3, the management of reagents, test solutions, culture media, etc., GMP put forward detailed management requirements. There is no check on their quality when they are purchased, and only problems are found in their use before they are solved. The management documents are not detailed, there is no requirement to memorize the date of opening the bottle, there is no period of time for use, and there is no batch number added to the prepared reagents. These are the things we need to pay attention to in the future. Record management, from the record of

3, seriously study GMP, the real integration of the simple terms of the profound ideas contained in the concept; such as retention of samples, why the amount of raw materials and auxiliary materials retained enough to identify, etc., a deep understanding of the meaning of each sentence, and in the work of the implementation of the new version of GMP and the old version of the GMP contents of the comparison

A part of the hardware requirements to improve

First, adjusted the sterile preparation production environment, the production environment is the same as that of the old version of the GMP. Adjusted the cleanliness requirements of the production environment of sterile preparations The new version of the major difference between the new version and the 98 version of the GMP is that: sterile preparations in the hardware has been greatly improved, with more emphasis on the production process of asepsis, purification requirements; in the soft management, the management of personnel, the handling of deviations, document management, quality control and quality assurance, quality review and so on has been greatly improved.

The second is to increase the requirements of equipment and facilities

The plant facilities are divided into production areas, storage areas, quality control areas and auxiliary areas were designed and layout requirements for the design and installation of equipment, maintenance and repair, the use of cleanliness and status of the labeling, calibration, and other aspects of the specific provisions.

Second, strengthened management requirements

First, improve the requirements for personnel

Institutions and personnel part, the quality of the authorized person and the person in charge of the enterprise, the person in charge of the production management, the person in charge of the quality management of the drug manufacturers as key personnel, and from the academic qualifications, technical titles, experience and other aspects of the qualification requirements of key personnel. The newly revised GMP puts forward the concept of quality authorized person for the first time, and includes the quality authorized person as the key personnel of drug manufacturing enterprises. All the drugs of the enterprise, need to be approved by its factory, this person is the first person in charge of the quality of the enterprise, in the Drug Administration to be filed, the quality of authorized persons have strict qualification requirements.

Secondly, it is clearly required to establish a pharmaceutical quality management system

The new version of the quality management of a separate chapter, enterprises must establish a comprehensive quality assurance system. The new GMP to improve the quality management of a level, the entire pharmaceutical company from the highest leadership to employees, are responsible for the quality, the development of their own management program. The new version of the drug GMP in the "General Principles" added to the enterprise to establish a quality management system requirements to ensure the effective implementation of drug GMP.

Third, the refinement of the operating procedures, production records and other document management requirements

In the document management, the new version of the GMP significantly increased the content of the document management requirements, increased the scope of the document management, all product quality and product quality related to the production of standards, production prescriptions and procedures, records, reports and so on, all the GMP document management scope. Clearly put forward according to the standards or procedures for the operation, the formation of various types of records, reports, etc. are documents, must be systematic management, and put forward the concept of batch file, each batch of drugs should be batch file, including batch production records, batch packaging records, batch inspection records and drug release audit records, batch sales records and other batch of product-related records and documents. The batch file should be stored and archived by the quality management department. This makes the whole drug production quality record management to form a complete system, to facilitate product quality traceability and improvement.

Third, around the risk management added a series of new systems Quality Control and Quality Assurance chapter, increased change control and deviation processing, corrective and preventive measures and product quality review and analysis are also added this time, these aspects of the cross in the word: quality risk management. Corrective and preventive measures aimed at involving product quality in all aspects of the factors, the existence of the problem of systematic generalization, analysis and summary, so as to take forceful and feasible measures to solve the problem, and indeed to ensure the quality of medicines.

The production quality management process of drugs is the implementation and embodiment of the requirements for registration and approval. The new version of the drug GMP in several chapters have emphasized the consistency between the production requirements and the registration and approval requirements.

The chapter on product release and recall, originally called retrieval, is now called recall, emphasizing the management of enterprise sales, while strengthening the interface with the "Administrative Measures for Recall of Drugs", which stipulates that enterprises should recall marketed medicines with potential safety hazards, and at the same time refining the management of recall, requiring enterprises to set up a product recall system, designate a special person in charge of executing the recall and coordinating the related work, and formulate a written The company is also required to establish a product recall system, designate a person responsible for the implementation of the recall and coordination of related work, and formulate written operational procedures for recall processing.

The core of GMP is to ensure that the quality of drugs is constant, the new version of GMP has strengthened the requirements and management of people and software, focusing on ensuring standardized production processes. In the GMP implementation and transformation process, the software upgrade is the lowest cost, the highest efficiency, a set of systematic scientific software can even make up for the lack of hardware and personnel quality. A good software system should have the following six characteristics, namely, systematic, completeness, accuracy, consistency, traceability and stability. This requires companies to mobilize staff according to the requirements of the new GMP, from every detail and link to start, the enterprise's existing software revision, integration and transformation, and effectively improve the level of enterprise software and operational capacity.

During the training period my deepest impression is the third morning of the practical training, the teacher explained to us a lot of requirements in the training workshop, and then we went to visit the training workshop, the teacher urged us to wear a white coat, to the training workshop, the teacher told us to look at that the correct procedures to enter the workshop, in order to maintain the cleanliness of the workshop, in order to get into the habit of doing so, all in accordance with the requirements of the GMP! Take off your own shoes, into the shoe cabinet, turn around, put on clean work shoes, into a locker room, take off outerwear, wash your hands and dry, into the second locker room, put on a work cap, to cover hair and ears, put on a mask, to cover the mouth and nose, put on a clean suit, zipper up the zipper, put on a clean pants, pants waist end outside the blouse, the side, so that you can enter the production workshop, a locker room, found that the inside of the design of a good Special, the ground are rounded corners, said to prevent the growth of microorganisms, even the air is also filtered, and the flow of people and logistics are separate, and reverse, we looked at a variety of preparations for the preparation of the machine, the teacher also explained to us, we usually eat the medicine are and these machines manufactured, so that we have a great deal of fun.

The rest of the training time we are learning theoretical knowledge and go to the computer room to operate the GMP training software. My biggest feeling is that I love quality with my heart. Doing a line love a line, do quality love quality; only then can really do well. In the quality of the field of continuous breakthroughs in the self, to be an enterprising person. Drug manufacturers only established a complete set of pharmaceutical production quality management system and strict implementation of GMP standards, in order to achieve the production of drugs in mind, so that each batch of drugs qualified to the market, serving the general public, drug manufacturers only in the implementation of the GMP process, to do the "whole process, all-round, full participation "The only way to make the quality of the drugs produced "stable, reliable and high quality" is to implement GMP in the pharmaceutical manufacturing enterprises.

Time flies, practical training is so the end, this practical training so that I understand the development of medicine is a bright, found that my front is a direction of the road, is the stage to success!

GMP practical training experience 4

In order to consolidate the results of classroom teaching, mastery of course knowledge, the college for us to organize this pharmacy internship. In this summer vacation, our group of 19 college students came to Nanjing Rishengchang Biotechnology Co., Ltd. for a 14-day visit and internship. Under the teacher's teaching, we learned a lot of knowledge that is not in the textbooks through field trips, serious study, watching the production process and other ways to link theory with practice.

First, the internship company

July 12, we came to the Nanjing Rishengchang Biotechnology Co.

Rishengchang Pharmaceuticals was founded in August 1999 in Taiyuan, Shanxi Province, in 2003 the headquarters moved to Nanjing. It is now a large pharmaceutical group with 2 GMP production bases, 5 marketing companies and 1 drug research center. Rishengchang has 10 GMP production workshops and 12 production lines, including powder, bulk, premix, granule (with Chinese medicine extraction), oral solution (with Chinese medicine extraction), small volume injection, large volume injection, disinfectant (solid, liquid), insecticide (solid, liquid), Chinese medicine extraction (licorice infusion), additive premixed feed, etc., with an annual production capacity of over 100,000 tons, and is one-time GMP certified in China's animation and protection industry.

The company has developed "Astragalus orchid cysticercosis drink", "Sanlin Combination", "Tisuoxian", "Qinggong Gestation Promoting Treasure", etc., which are well known in the market. "and other well-known products in the market; which "astragalus blue cystic disease drink" "clear the womb to promote pregnancy treasure" and other achievements won the national invention patent, the company is currently in the "high concentration compound sulfonamide solution technology", "the true solution of sulfonamide" and "the high concentration compound sulfonamide solution". At present, the company has developed "high concentration compound sulfonamide true solution", "large livestock infertility technology", "composite high concentration multi-dimensional solution", "food attraction and growth promotion technology", The "biological mosquito control technology" and other fields are still in the same industry in China.

Second, the internship harvest

1. GMP workshop visit

12 afternoon, we visited the solid preparation workshop, where the production department of the Zhang experience to us about the classification of preparations: granules, tablets, capsules. The production process of granules is: peeling → crushing → mixing → total mixing → inner packaging → outer packaging. The production process of tablets: tablet pressing → internal packaging → external packaging, packaging materials such as chaise longue film. Its equipment is mainly tablet press, total mixer, granulator. Later in the liquid production workshop we visited the process of water purification: general water → machine filtration → quartzite filtration → activated carbon filtration → machine filtration → ultraviolet sterilization, in turn, the use of quartzite filters activated carbon filters machine filters. Clean area temperature is generally 18-26 degrees Celsius. Humidity is 45%-60%.

2. Workshop production internship

13 we began the formal internship life. We 19 people were divided into two groups, respectively in the powder workshop and oral liquid workshop. In the first week, our group was divided into the oral liquid workshop. We did not participate in the preparation process of oral liquid, but only did the final filling and packaging work. Although it seemed to be the simplest packing and filling, it was not as good as we thought. At the beginning of the labeling is very slow,

Later slowly familiar with the method of paste, speed a lot faster, but will often put the labeling bad, and then we have repeated work, careful thinking, and finally will be able to paste the labeling fast and good. After labeling the bottles should be packed into a special foam box, all loaded and then in a box of boxes to the box, and finally a unified post sealing labeling box. I was the first contact packaging things, feel very fresh, very fun, so dry is also very energetic, do not feel tired, but then do a long time to feel this work is very boring and boring, so then really admire the staff working in this workshop, some of them have been working here for 3, 4 years.

In the following days, we went outside the workshop to help with the production of insecticides. Again, we performed the same filling, sealing and labeling tasks. This is although the sealing is all done by machine, but some bottles will have their mouths unsealed, so someone has to be on hand at all times to pick out those bottles that don't have their mouths sealed. Moreover, we found that before sealing, some large-capacity bottles can not be tightly screwed manually, but also need to use a special wrench to screw, so that the sealing of the seal will have a much higher chance of sealing. In fact, similar to this seems extremely simple work, to do a good job is not so easy, to be diligent in observation to find the tricks to do a good job.

The second week, due to the transfer of work, our group to the powder workshop. In the powder workshop, we did the work of sub-metering and packaging. When we started to do the work of packing powder into bags, because we did not know the amount of measurement very well, so when we packed the bags, it was always too much or too little. This brought trouble to the weighing students and slowed down the production progress. Later, we gradually realized how much we should put into the bag when weighing, and then the progress was accelerated. After that, we put small bags of medicine into carton boxes, weighed them, and finally sealed the boxes with a packaging machine. During this period, we also used the factory's new inkjet printer, the sealing of the finished vials of medicine to spray code, which allows us to have a more in-depth understanding of the whole process of packaging.

3. Internship thoughts

Although it is just a short two weeks of social practice, but it makes me benefit a lot. Out of the classroom, into the practice. To personally experience the knowledge learned from practicing textbooks. In this short ten days of internship, let us learn about the pharmaceutical expertise, broaden the horizons, more importantly, in the treatment of enterprises and their own development of knowledge, by a considerable shock. It is no exaggeration to say that this practice has changed some of our previous completely wrong views.

GMP practical training experience 5

In the first day of the factory, let all the internship fresh graduates in the conference room for the pharmaceutical factory training, first of all, let us understand the layout of the factory, workshop layout, familiar with the relevant principles, to give us an introduction to the production of various workshops and workshop leaders of the drugs. Then the managers of each department explained to us the workshop process, safety, fire knowledge and corporate culture, so that we were familiar with the process of drug production (from raw materials to finished products), learned the material flow of each workshop, strengthened the knowledge of GMP and the knowledge of safety learning, combining theory and practice. After we trained these knowledge long to assign us to the various workshops to start the workshop internship.

I was assigned to the new oral preparation workshop, with me there are more than 20 fresh graduates. This workshop is ___ just built a new workshop, we just arrived at the workshop, our director said we work together, the workshop in February to participate in the GMP certification. Then he introduced us to the main drugs produced in the workshop. This workshop mainly produces tablets, capsules and granules. The main products are fluconazole tablets, artificial oxalic acid metronidazole capsules, Yinhuang capsules, metronidazole fenbufen capsules, stone drench granules, a clear granules and so on. The director assigned us positions, and I was assigned to the tablet pressing position at first, and followed the tablet pressing master to learn a lot about the tablet pressing machine and the tablet pressing process. I realized that a small tablet like that needs so many processes to be made successfully. Later, I was assigned to a new position, packaging. In the packaging although not as much as the tablet pressing process knowledge is needed, but I learned in the packaging is very happy. Each of us new trainees had a good relationship with the masters of packaging. In this way, through the efforts of all of us, we passed the GMP certification in February. Each of us new trainees are happy from the bottom of our hearts.

In a few months of internship, each of our new trainees like a real employee with their own work card, feel that they have not been a student, and the same as the working class to go to work, get up at 7:00 a.m. every day, 7:50 a.m. on time to the workshop to change the work clothes to begin to enter the work state, the internship process, I abide by the company's systems, to do not sleep on the post, to the post, breaking the post, not Absenteeism, there has been no major accidents, learning from experienced masters, seriously complete the work tasks assigned by the leadership, and the professional knowledge learned in the university to apply to the work of the rest of the day off to expand their professional knowledge and job safety knowledge, so that they are more competitive in the work.

Time flies, see our six-month internship will be full, I think the internship is a fresh university graduates for a very important experience, the internship is a platform for us to leave the school to contact the community, the most real feeling of the community a window. This six-month internship in the limited company has taught me a lot of things and is of great significance to me. It allows me to improve my communication and interpersonal relationship skills, and to experience working life in advance. In the process of internship, enrich their professional knowledge, accumulate work experience, for the future on the workplace to lay the foundation, but also to find their own shortcomings, make up for the early, enhance their ability to adapt to society. Let me more profound understanding of society, more convenient to integrate into society, it not only makes me in the theory of pharmaceutical technology in this field has a new familiarity, but also in the practical ability to improve, and really do the learning to use, so that I learned a lot of books can not be learned, effective exercise of their own, long insights, to open up the field of vision, internship is the school we learned the theoretical knowledge applied to the actual The internship is an attempt to apply the theoretical knowledge we learned in school in practice, is the first step towards society, through this internship, I found a lot of problems, their shortcomings, deficiencies, should have abandoned bad habits. Let me know that the knowledge I have learned is too shallow, the lack of professional knowledge in the practical application. Let me better understand that I need to learn too much, so that I understand that I must know more in order to have a place in today's highly competitive society.

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