Table of contents
1. GMP concept, GMP standard.
• What is GMP?
• GMP standard
2. What is CGMP? cGMP . standard
• What is CGMP?
• What is the CGMP standard?
3. EU GMP concept, EU GMP standard
• What is EU GMP?
• EU-GMP . Standard
4. Concept of GMP WHO, GMP WHO Standard
• What is GMP WHO?
• GMP WHO standard
• WHO GMP document
1. GMP concept, GMP standard
– What is GMP?
GMP (Good Manufacturing Practices) is Good Manufacturing Practices, which includes general principles, regulations and guidelines for basic content on production conditions applicable to establishments manufacturing and processing food and pharmaceuticals. products in order to control the factors affecting the process of forming product quality from the design, construction and installation of factories, equipment and processing tools; conditions of service, preparation for processing to processing; packaging, preservation and human control activities during processing, processing and production.
– What is GMP standard?
GMP – Good Manufacturing Practice is a system of good manufacturing practice standards to control factors that can affect the process of forming product quality, in order to ensure products of the best quality. GMP is a basic standard, a condition for the development of an ISO food safety management system.
GMP standards relate to every aspect of the manufacturing process and quality control, controlling hazards from the design and installation of the plant, processing equipment, machinery, equipment, inputs, to the packing, packaging, processing and storage specifications as well as the training and hygiene of the staff…. This helps to bring a systematic, logical and scientific method of quality management, minimizing risks in business.
In order to meet GMP standards, the following must be complied with:
– Workshops and processing facilities are designed and built in accordance with the sequence of the processing technology chain, divided into safe zones such as: gathering raw materials, processing, packaging, preserving… This process helps to ensure that there is no cross-contamination between raw materials, semi-finished products and finished products; between food and packaging materials, cleaning chemicals or scrap.
– Factory hygiene control: That is, the factory, equipment, tools and other physical facilities always reach the permissible standard of hygiene. In addition, sanitary facilities, water supply and drainage systems, product contact surfaces, by-products, waste, containers, and personal belongings must always be in a state of hygienic standard. and works fine.
– Processing process control: The manufacturer has measures to control quality with raw materials and processing; monitor and supervise sanitation activities; take precautions against possible product contamination; testing the microbiological, chemical and impurity criteria at the necessary stage to determine the risk of infection.
– Requirements on workers’ health: The manufacturer has a regime of regular health checks for employees to detect, treat and isolate people with infectious diseases to avoid spreading. People who come into direct contact with the product must strictly observe hygiene regulations.
– Control the storage and distribution stages in transportation and preservation of finished products, ensuring to avoid contamination by physical, chemical, and microbiological agents, etc., not to degrade the product.
2. What is cGMP? cGMP . standard
• What is cGMP?
cGMP – (current Good Manufacturing Practice) means current good manufacturing practice. That is technology, production process, production equipment and industry standards, new inventions in technology, science. This reminds businesses that implement GMP, they must use equipment, technology, production processes and scientific information in accordance with the standards at the time of application.
• What is the cGMP standard?
What does cGMP stand for? is an acronym for Cosmetic Good Manufacturing Practice – that is, good manufacturing practice for cosmetics, which is a branch of GMP. The purpose is to provide guidance and quality assessment standards in the cosmetic manufacturing process, techniques and administrative factors affecting product quality, always ensuring that products meet quality standards and safe.
With the current situation, especially the cosmetic market, is flooded with cosmetic products of unknown origin, origin, and unsafety from ingredients and pharmaceutical formulas that are not effective for consumers. use. Therefore, good cosmetic manufacturing practice is an affirmation of the factory’s production capacity as well as providing customers with the best and safe product quality for customers. The cGMP standard not only helps control the quality of safe and good products, but it also controls objects such as:
+ Factory, Workshop
+ Personnel
+ The machines and equipment
+ Production hygiene, environmental hygiene, personal hygiene.
+ Product quality: prototype
+ Production process: Worker’s actions, fulfillment of requirements for raw materials, product standards, recipes, physical conditions of production, assessment of supplier’s supply. raw material supply.
+ Checking: raw materials, semi-finished products, products, workers’ actions, supplier evaluation, hygiene.
+ Handling non-conforming products to resolve customer complaints.
+ Documents, records of implementation…
In our country, according to the decision of the Ministry of Health, cGMP standard is a mandatory standard applied in factories, production workshops, production facilities… to ensure product quality and safety. A cosmetic factory that wants to be known for its prestige and quality needs to apply cGMP standards. The cGMP standard basically and comprehensively improves the sanitary and safety conditions of the production plant as well as the production activities and meets the requirements of the Law on food safety management.
3. EU GMP concept, EU GMP standard
What is EU GMP?
EU-GMP is a guideline for good manufacturing practice issued by the European Medicines Agency (EMA) – an agency under the European Union EU, responsible for scientific evaluation, testing and drug safety monitoring within the EU.
EMA – The European Medicines Agency is an affiliated agency of the European Union (EU) located in London, operating since 1995. This is the body responsible for scientific evaluation, control and control. Safety inspection and monitoring of medicines in the EU.
Pharmaceutical manufacturing facilities in Vietnam or any other countries outside the EU that want to obtain EU-GMP certification must obtain the approval of inspectors and be granted a certificate of conformity. EMA’s EU-GMP standard. Up to now, along with PIC/S, EU-GMP standard is one of the highest quality standards.
• EU-GMP . Standard
EU-GMP standard is a whole system of standards developed and issued to control problems and activities in pharmaceutical production facilities to ensure the production of drugs, functional foods, protective foods. high quality health and safety for users. The scope and control objects of the EU-GMP standard include:
– Personnel
– Factory
– Device
– Production hygiene, environmental hygiene, personal hygiene
– Production process: worker’s manipulation, fulfillment of requirements for raw materials, product standards, formulations, physical conditions of production, assessment of supplier’s supply. material supply
– Product quality: sample testing
– Check: raw materials, semi-finished products, products, worker’s actions, supplier evaluation, hygiene
– Handling nonconforming products, resolving customer complaints
– Documents and records of implementation…
4. Concept of GMP WHO, GMP WHO Standard
• What is GMP WHO?
GMP is part of a quality management system that ensures control of plant (infrastructure) conditions, human conditions, and control of production processes to meet safety and health standards. provide consumers with the elimination of the risk of cross-contamination and confusion.
• GMP WHO standard
GMP WHO is a good manufacturing practice guideline developed and first published by the World Health Organization in 1968.
GMP guidelines are issued to ensure that medicines, health foods, cosmetics and veterinary drugs are consistently produced and controlled in accordance with quality standards appropriate to their intended use. as well as comply with the provisions of the marketing authorization, and at the same time minimize the risks of uncontrolled by checking such as cross-contamination, confusion.
After developing GMP, establishments will prepare legal documents to be granted GMP certificate. This certificate helps to increase the reputation of the business in the eyes of customers as well as improve production efficiency and reduce the risks that are easily encountered in the production process.
The principles in the WHO GMP aim to strictly manage and minimize the risks that occur in the manufacturing process of medicines. The principles in GMP – WHO are:
1. All production processes are clearly defined, reviewed for potential hazards, and shown to be able to produce drugs, dietary supplements, and cosmetics that meet quality requirements.
2. Quality control testing must be carried out.
3. Have all necessary resources: Sufficient and properly trained staff, suitable premises and spaces, suitable equipment and services, label packaging materials standards, procedures and instructions have been developed, appraised and approved, stored and transported appropriately, fully staffed laboratory equipment for inspection throughout the production process. export.
4. Instructions and procedures are clearly written, easy to understand
5. Operators are trained to strictly comply with GMP standards
6. Fully record in the production process to show that every step is done in accordance with the procedures and instructions as well as easily find the cause when any deviation occurs, thereby taking corrective action. appropriate prevention and treatment.
7. Production and distribution records should be kept in a form to ensure easy traceability of the entire history of a production batch.
8. Preserve and distribute medicines, health foods, cosmetics, veterinary drugs in accordance with the guidelines in good drug distribution practice (GDP).
9. There is a systematic recall of any product being sold or supplied.
10. Complaints about products in circulation must be examined, the cause found, and appropriate action taken against the defective product and to prevent its recurrence.
The standards of GMP – WHO are increasingly strict but bring many benefits to businesses. Therefore, the investment in production lines meeting GMP – WHO standards is being focused on by businesses:
• Prepare the quality management system for HACCP certification
• Increase competitiveness with foreign products
• Show commitment to safe food production and sales
• Increase the trust and reputation of enterprises with customers and consumers, creating favorable conditions for enterprises to export drugs to difficult markets.
• Has a supportive effect when there is an assessment by the competent authorities or related parties.