The basic principle is as follows: 17:
(1) Pharmaceutical manufacturing enterprises must have enough qualified technicians suitable for the pharmaceuticals they produce to undertake pharmaceutical production and quality management, and clarify their responsibilities;
(2) Operators should be trained to operate correctly according to regulations;
(3) Ensure that the products are produced and controlled according to the approved quality standards;
(4) Written production instructions should be issued according to each batch of production tasks, and batch production instructions cannot be replaced by production plans;
(five) all production and processing should be carried out in accordance with the approved process regulations, and systematic inspection according to experience, which proves that drugs can be produced in accordance with quality requirements and specifications;
(6) Ensure that the production plant, environment, production equipment and hygiene meet the requirements;
(seven) materials, packaging containers and labels that meet the prescribed requirements;
(8) Suitable storage and transportation equipment;
(9) Strictly and effectively control and manage the whole production process;
(10) Verify the key steps of production and processing and the important changes caused by processing;
(1 1) Qualified quality inspectors, equipment and laboratories;
(12) Production records should be recorded manually or by a recorder during production, so as to prove that all production steps have been carried out in accordance with established regulations and instructions, and the products have reached the expected quantity and quality. Any deviation shall be recorded and investigated;
(14) The risk of affecting the quality of products during storage and sales should be minimized;
(15) Establish an effective system for taking back any batch of products through sales and supply channels;
(16) Understand users' opinions on products on the market, investigate the causes of quality problems, and put forward treatment measures and preventive measures to prevent recurrence.
(17) verify a new production process, production technology, equipment and materials, and prove whether the expected effect can be achieved through systematic verification.
Ten basic principles of GMP
What is GMP?
Short for Good Manufacturing Practice. Good manufacturing practices.
The State Administration of Pharmaceutical Products has formulated standard rules for personnel, plant facilities and equipment, production management, quality management and document management of excellent pharmaceutical production.
Purpose of GMP implementation:
Minimize pollution, confusion and mistakes in drug production.
The implementation of GMP has brought a new concept to drug quality. Drugs must not only pass the inspection, but also meet GMP requirements in the whole production process.
GMP certification:
The state implements the drug GMP supervision and inspection system for drug production enterprises (workshops) and drug varieties according to law and obtains recognition to ensure the stability, safety and effectiveness of drugs.
Scientific and advanced management methods to ensure stable, safe and effective drug quality.
International drug trade and drug supervision and management are important contents.
Development history of GMP:
Human society has experienced several major drug disasters.
1962, the us congress revised the federal drug and cosmetic law.
1963, the United States promulgated the world's first GMP.
From 65438 to 0967, the 2nd1World Health Assembly adopted the first draft of WHO -GMP.
1975 The drug quality certification system in international trade and the revised version of WHO -GMP were adopted at the same time, and GMP was officially announced.
1974, the Japanese government praised GMP.
1988 issued the Association of Southeast Asian Nations (ASEAN) GMP standard.
1992, the European community drug GMP(EEC-GMP) was published.
1992 mutual recognition agreement for pharmaceutical production inspection (PIC) was published in good manufacturing practice (PIC-GMP).
1980, 63 countries have implemented GMP.
Development of GMP in China
1982 trial version of drug production management standard formulated by China pharmaceutical industry company;
65438-0988 The Ministry of Health promulgated China's legal GMP.
1992, revised GMP promulgated by the Ministry of Health;
In June 1999, SDA (State Administration of Medical Products) promulgated the good manufacturing practice (revised 1998).
GMP certification
In July, 1995, 1 1, the Notice of the Ministry of Health on Developing Drug GMP Certification was issued, and the China Drug Certification Committee was established in the same year.
1998 On April 16, National Medical Products Administration established the Drug Certification Management Center (CCD) of the State Administration of Pharmaceutical Products.
Ten basic principles of GMP
1. Define the job responsibilities of personnel in each position.
2. When designing and building factories, facilities and equipment, we should fully consider the production capacity, product quality and physical and mental health of employees.
3. Properly maintain the plant, facilities and equipment to ensure that they are always in good condition.
4. Make cleaning a daily habit to prevent product pollution.
5. Carry out verification work to prove the effectiveness, correctness and reliability of the system.
6. Draft detailed rules to provide accurate behavior guidance for consistent results.
7. Seriously abide by the approved written procedures to prevent pollution, confusion and mistakes.
8. Timely and accurately record and file operations or work to ensure traceability and compliance with GMP requirements.
9. Establish quality in the production process by controlling all stages related to the product.
10. Conduct planned self-inspection on a regular basis.
Principle 1: define the job responsibilities of personnel in each position.
GMP requires that the personnel in each position can be competent for their own work.
Are we qualified for the work we undertake?
Do you have the knowledge and skills that your position should have?
Can you guarantee that you can do the work well the first time and every time?
You should be clear about your job responsibilities and master what you should know and know in your post.
The requirements of pharmaceutical technology and post are constantly developing, which requires continuous learning and training.
GMP needs competent employees like us:
Principle 2: During the design and construction of factories, facilities and equipment, full consideration should be given to production capacity, product quality and physical and mental health of employees.
The design and construction of plant facilities and equipment shall meet the following conditions:
production capacity
product quality
Employee safety and physical and mental health
Factors to be considered in the design and construction of factory facilities and equipment:
Provide sufficient operating space.
Establish a reasonable production process.
Control the internal environment
Design and selection of equipment
Principle 3: properly maintain facilities and equipment to ensure that they are always in good condition.
Consequences of improper maintenance of factories, facilities and equipment:
As a result, the products are reworked and scrapped, so they cannot leave the factory.
Complaints, returns, repossession and possible legal disputes
Influence on corporate image, etc.
It is very important to establish a maintenance plan for factories and equipment and implement it carefully.
Written procedures shall be formulated to specify the inspection and maintenance items, cycle, location, methods and standards of each equipment.
Make maintenance records: each key equipment should have use records, cleaning records, maintenance records, lubrication records, etc.
When there are abnormal situations that may affect the quality of products, emergency measures should be taken before starting production operations.
Principle 4: Make cleaning a daily habit to prevent product pollution.
Cleaning is an effective measure to prevent product pollution.
Drug production attaches importance to cleaning work, and the challenge of cleaning work is endless.
Our goal is to make cleanliness a part of GMP lifestyle.
Clean standards and clean written procedures should be established.
In daily operation, attention should be paid to:
Maintain good personal hygiene habits.
Change clothes and wash your hands; Cleaning and disinfection; Report for a rest.
Strictly follow the written cleaning procedures.
Record the cleaning work timely and accurately.
Report any situation that may cause product pollution in time.
Take necessary measures to prevent rats and insects from entering.
Check the water treatment system and air purification system regularly.
Properly dispose of production waste.
Thoroughly clean production equipment
Principle 5: Carry out verification work to prove the effectiveness, correctness and reliability of the system.
Verification: a series of documented activities that prove that the process, equipment, materials, activities or systems of drug production can truly achieve the expected results.
Verification is an organized activity.
Verification can prove that the process, equipment, materials, activities or systems of drug production can indeed achieve the expected results.
Through verification, we can ensure that our production process can always meet the requirements of predetermined standards.
When every system or process of drug production is verified, we are fully confident that the quality of the products produced can always meet the requirements of quality standards. In order to maintain this confidence, we must strictly follow the verified written procedures.
After the verification process, the generated records are meaningful.
Air purification system verification
Process water system verification
Verification of main process equipment
Sterilization equipment verification
Equipment cleaning verification: verification of liquid medicine filtration and filling (sub-packaging) system.
Verification of inspection instruments
Verification of main raw and auxiliary materials change
Production technology and its change verification
Equipment cleaning verification
Verification of inspection method ...
Principle 6. Draft detailed regulations to provide accurate behavior guidance for achieving consistent results.
Habits and procedures
Our lives are controlled by programs.
The procedure of getting up every morning
Procedures for entering the production area
Main differences between the procedures followed in daily life and work:
Is it a written document?
The core of GMP is to establish written procedures for each operation (or work) of production and quality management.
Written procedures are the first step to ensure that GMP requirements are met, the operation (or work) process is controllable and the results are consistent, which can control the production and quality management process of drugs and minimize the possibility of pollution, confusion and mistakes.
Six functions of programming:
Standardization-standardized behavior
Operating instructions-training materials and operating instructions for new jobs
Operating Reference-See
Control-inspection and evaluation
Audit-historical audit
Filing-evidence, traceability
How to draft a written procedure
It should be clear, accurate, understandable and logical.
Draw the flow of operation (or work) first.
Use language that executives can understand.
Enhance the impression with charts
Pay attention to packaging
Principle 7. Seriously abide by written procedures to prevent pollution, confusion and mistakes.
The most effective way to ensure that the production operation meets GMP requirements;
Carefully follow every step of the written procedure.
"Shortcut" in the operation process
The method in the written procedure may not be the best or the most effective.
Experienced employees may find ways to save time, cost or operation.
How to deal with the "shortcut" in the operation process
Many seemingly shortcut methods have hidden defects, which will cost us in the long run.
Each step of the written procedure has its specific purpose and significance, which may not be meaningful to the current operation, but may be the preparation, inspection or review of other operations.
If you really have a good idea or operation method to improve the operation (or work), you should report it to the supervisor and the authorized personnel will evaluate the change or improvement.
If it proves to be a good and effective method, the modification of written procedures can be approved.
Without the approval of the department head and the quality department, our operation cannot deviate from the written procedure.
Prison records
Written procedure is the most useful tool to ensure product quality.
Written procedures are standard documents produced after careful consideration or verification, which can help us obtain consistent quality of work.
Written procedures are as important to experienced employees as to new employees.
Written procedures ensure that our actions meet GMP requirements.
Principle 8: Record and file operations or work timely and accurately to ensure traceability and compliance with GMP requirements.
Importance of records
Recording is to record the events that have happened or the known facts and keep them properly.
GMP requirements
Inspection contents of the state drug supervision and administration department
Investigation basis in case of quality problems or user complaints.
Keeping accurate records is also a good work habit.
Record range
Material management record
Management and operation records of factory facilities and equipment
Production and operation management records
Quality management and inspection, inspection records
act of sale
Personnel training and health inspection records ...
Requirements for records
Management procedure for establishing records
After the homework (or work) is completed, it should be recorded timely and accurately.
The handwriting should be clear, the content should be true and the data should be complete.
It shall be recorded and signed by the operator himself.
Any deviation in the process should be reported, handled and recorded in time.
You can't write memoirs or record them in advance.
Principle 6-8: Review
Write down what you want to do.
Do what you write well.
Remember what you did.
Principle 9. By controlling all stages related to the product, quality is established in the production process of the product.
The defects of our products are usually caused by pollution, confusion and mistakes.
The purpose of implementing GMP is to prevent pollution, confusion and mistakes through process control and ensure product quality.
Main links of control:
Material control: procurement control; Storage control; Inspection control.
Facilities and equipment control: design and construction control, verification, use and maintenance control.
Production process control: written procedures; Original records; Process parameters; Process hygiene; Independent review; Packaging label control; Clean up this area.
Inspection process control
Finished product storage and sales control: inspection and audit before leaving the factory; Storage control; Sales records.
After sales service.
QA/QC can only inspect or check the quality of products formed in the production process.
Every employee in an enterprise has a direct impact on product quality.
Principle 10: Conduct planned self-inspection regularly.
Establish written self-inspection procedures, define self-inspection items and standards, and organize self-inspection regularly.
After the completion of self-inspection, make a self-inspection report:
Self-checking result
Evaluation conclusion
Improvement measures and suggestions
Self-inspection of daily work:
Have I received the necessary education, training and skills training, and am competent for this position?
Have I mastered the "should know and should know" of this position?
Do you understand the responsibility of product quality?
Can you do things well the first time and every time?
Do I record in time and accurately according to the requirements of recording?
Can the written procedures implemented give me clear guidance in my work?
Can I understand whether the written procedure can be strictly followed?
Do I regularly check the written procedures to ensure their accuracy and effectiveness?
What should I do when I find a shortcut or a better operation method?
Whether personal hygiene meets the requirements and whether clothes are changed as required.
Are equipment, containers and utensils cleaned in accordance with written procedures to ensure that they are in a ready-to-use state?
Is it necessary to report the abnormal situation that may contaminate the product immediately?
Can we reduce the chances of pollution, chaos and mistakes by controlling the internal environment?
Is the equipment inspected, maintained and maintained according to written procedures?
Is the use, cleaning, maintenance and lubrication of the equipment recorded as required? Did you report the abnormal situation to the supervisor?
Extension of GMP
Good management practice
Work quality management standard
Job requirements and training
workflow
working standard
Work record
Work plan, summary and evaluation