learning experience
I am grateful for this learning opportunity. On the one hand, the new version of GMP was introduced. After repeated study, I don't know much about the new GMP. I wonder how much GMP has changed from hardware to software. If the workshop does not fully understand GMP in a short time, the work can not be carried out in an orderly manner. I am very anxious, so I am grateful to participate in this GMP study.
Through this GMP study and the teacher's explanation, I learned more knowledge:
First, understand the formation of new GMP:
1. Inheritance is the inheritance of GMP version 98 (the content of GMP version 98 is contained in 10 and should be implemented; There are provisions in version 98, and it will be implemented if there are no provisions in version 10).
2. Innovation 98 GMP is about conformity, and 10 GMP is about applicability (10 GMP contains many principled things, and each unit can implement GMP in its own way according to the characteristics of its own products, focusing on product quality; It improves the applicability and greatly increases the difficulty of counterfeiting. A lot of space has been added to make the new GMP more instructive, inspective and operable, and more in line with the regulatory requirements of product applicability).
3. Learn from and absorb international advanced experience to achieve consistency with the drug GMP of the World Health Organization.
2. Understand the main features of the new GMP.
1. Strengthen
Second, I learned how to read new GMP terms.
1. Choose your words carefully and don't weigh them repeatedly.
2. Look at the specifications from the system point of view, and don't simply look up the numbers.
Don't feel unattainable or easy.
Third, have more understanding or understanding of the terms of the new GMP itself.
The main difference between 1. And GMP version 98.
The space has been greatly increased. The new version of drug GMP absorbs international advanced experience, combines China's national conditions, implements the concepts of quality risk management and whole process management of drug production according to the principle of "paying equal attention to software and hardware", pays more attention to science, emphasizes guidance and operability, and achieves consistency with the World Health Organization's drug GMP.
Enterprises should establish a quality management system suitable for their own characteristics according to the specific objectives of their own product stages.
2. It embodies the principle of paying equal attention to hardware and software in the new GMP.
For example, in the clause on preventing pollution and cross-contamination: "Only by taking measures to prevent confusion or cross-contamination and proving that there is no possibility of confusion or cross-contamination, can production be carried out simultaneously in the same operation room. Such as: outsourcing, Chinese medicine extraction, etc. . It not only emphasizes the necessity of physical isolation, but also emphasizes the significance of scientific and effective software.
3. The new GMP is neither unattainable nor easy.
(1) such as "packaging intermediate control" In fact, our factory has done a lot of packaging intermediate control, which is very detailed and experienced, but our intermediate control inspection records are few, so the packaging intermediate control records can be recorded according to the original intermediate inspection management behavior, which is actually a very simple matter, but it also needs to be a comprehensive system.
(2) such as material balance
"Material balance is a quality index. The purpose of material balance control is to prevent confusion and wrong quality problems, which is conducive to timely discovering material misuse and abnormal loss. It is unrealistic to unilaterally pursue the material balance of 100%. The material balance rate meets the set limit; The limit range should be confirmed by process verification. "
The material balance record of packaging material inspection in many pharmaceutical factories is 100%, which is one-sided pursuit of material balance. Packaging materials come from manufacturers, sometimes more or less, but their deviation limits can be obtained through verification. If the limit is exceeded, we need to find out the reason. It is also possible that the material deviation from the manufacturer exceeds the limit during verification, just to find out the reason.
Fourth, through the teacher's explanation, I learned more knowledge:
(1). For example, Article 84 Production equipment shall be cleaned according to detailed operating procedures.
Explanation: ① The operating rules for cleaning production equipment should specify specific and complete cleaning methods, names and preparation methods of cleaning equipment or tools, cleaning agents, methods for removing the marks of the previous batch, methods for protecting cleaning equipment from pollution before use, the longest storage time of cleaning equipment, and methods for checking the cleaning status of equipment before use, so that operators can clean all kinds of equipment in a repeatable and effective way.
(2) If it is necessary to disassemble the equipment, it should also explain the sequence and method of disassembling the equipment; If it is necessary to disinfect or sterilize the equipment, it should also explain the specific disinfection or sterilization method, the name of the disinfectant and the preparation method. When necessary, the maximum time interval between the end of equipment production and cleaning shall be specified.
③ Basic principles of cleanliness
-New equipment and containers shall be decontaminated, degreased and waxed according to the specified methods.
-Establish the corresponding standard cleaning procedure according to the purpose, and verify the cleaning method, the longest storage time from cleaning to use, the longest storage time from use to cleaning, the continuous use time and the longest pause time according to the management procedure of cleaning verification.
—— In the longest standing time after equipment cleaning, the first contact time between equipment and materials is the equipment start-up time.
④ General contents of cleaning procedures:
-Degree of disassembly of equipment;
-Parts to be cleaned and their locations;
-Detailed cleaning steps (including cleaning tools used in each step, time requirements, etc.). );
-Selection of cleaning water and cleaning agent;
-indicate the cleanliness and validity of the equipment;
-Inspection after cleaning and handling of cleaning expired equipment;
-Storage conditions of cleaning equipment;
-Check the equipment before use.
⑤ Cleaning time
-Continuous production
-Intermittent production
-Production stopped.
-After repair and maintenance
-Not using the equipment for a long time
⑥ Cleaning type:
-Daily cleaning: the clean state that should be maintained in normal production.
-After-shift cleaning: clean the production site and equipment after each shift.
-Batch-changing cleaning: cleaning when different batches of the same product are changed.
-Thorough cleaning: thorough cleaning (including cleaning and rinsing) when replacing products, and cleaning when continuously producing the same products to the specified batch number or time.
(2). Such as: supplier audit.
Re-understanding of supplier audit, audit is not only to affirm or deny a supplier, but to better understand and communicate, so as to adopt feasible methods to find quality problems in production and take corresponding measures to prevent quality accidents. At present, our workshop's understanding of the materials used in production is basically blank, because in the past, we all stood on the position of affirming or denying a supplier, which did not play a good role in communication and understanding.
(3) The design of records should avoid filling in errors:
Xxxx weighing record
Project Name Project Number Supplier
Name The model of the scale shall be weighed, weighed, weighed and checked by inspectors.
××× ××× ××× ××× ×××
××× ××× ××× ××× ×××
××× ××× ××× ××× ×××
The xx part of the above record form is printed out, especially after the weighing quantity is typed out, there will be a reference to the weighing quantity, the material name will be typed out for review, the material number will be typed out to know whether the material number has changed in time, and the weighing model will be typed out for correct selection to avoid filling errors. However, when the material number changes, the above records should be changed in time.
Verb (abbreviation of verb) has a further understanding of risk management and risk assessment.
Figure 1 Weighing Table Design
The picture shows the design of weighing platform in weighing room. The picture shows that the design position of the weighing platform is in the downwind direction, close to the exhaust port, and the height of the weighing platform is appropriate. If it is too high, the generated dust particles are not easy to be directly discharged. If it is too low, the wind will blow on the material through the human body during the weighing operation, causing material pollution.
Through the teacher's picture display and explanation, we broaden our horizons and increase our knowledge.
draw
Visual management combines the connotation of cost management and verification management. It can be seen from the visual management chart of "Cleaning Procedures for Cleaning Work Clothes Surface" that the adhesive roller can be used for 5 times, and each adhesive roller can be used for several times. It can be clearly seen from the fixed management diagram that a new adhesive surface needs to be replaced after five uses. From the use and management of glue pipes, the concepts of visual positioning management and cost management are integrated (cost management is based on scientific verification).
Seven. others
In the evening after class, I listened to the propaganda and training of equipment and instrument manufacturers, and took the opportunity to understand the types and methods of dynamic detection instruments for suspended particle counters.
In a word, taking part in this GMP study 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. There is a lack of communication with teachers in this study, and there are still some places that 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. It needs a good combination of professional knowledge and technology, and adheres to the principle of quality assurance and quality improvement, so the implementation of GMP is meaningful.
To achieve consistency with the World Health Organization's drug GMP, the goal is far-reaching, significant and arduous.