what is GMP standards as well as the principles that the most drug and functional food manufacturers must follow. Join riclix.com to find out the above definitions in detail through the following article.

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1: GMP concept, GMP standard.

2: EU GMP concept, EU standard GMP3: GMP concept WHO , GMP standard WHO4: What is cGMP? cGMP . standard

1: GMP concept, GMP standard.

1.1: What is GMP?.

GMP (Good Manufacturing Practices) is a guide to good manufacturing practice, applicable to food and pharmaceutical manufacturing and processing establishments in order to control factors affecting the process of product quality from the outset. design, construction and installation of factories, processing equipment and tools; conditions of serving, preparation for processing to the processing process; packaging, preservation and human control activities during processing. It deals with every aspect of the production process and quality control.

What is GMP?

1.2: GMP . Standard

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 product quality. best quantity. GMP is a basic standard, a condition for developing an ISO 22000 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, equipment and machinery, input materials, to the packing, packaging, processing and storage specifications as well as the training and hygiene of the staff…. This helps to bring about a systematic, logical and scientific quality management method, minimizing risks in business.

GMP standards in drug manufacturing are GMP standards of good drug manufacturing practice. Due to the strict requirements of the current drug market, a pharmaceutical company needs to apply GMP standards to ensure technical and management conditions to create quality and safe final products.

What is GMP standard?

5 things to follow in a GMP clean room.

– 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.

– Control of processing: 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.

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– 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.

– Controlling the storage and distribution stages in transportation and preservation of finished products, ensuring to avoid contamination by physical, chemical, and microbiological agents, etc., without decomposing the product.

2: EU GMP concept, EU GMP standard

What is EU GMP? Europe) granted the certificate of meeting EU GMP standards.

Up to now, along with PIC/S, EU-GMP standard is one of the highest quality standards.

2.2: EU-GMP . Standard

– “Good Manufacturing Practice – EU” granted by EMA- European Medicines Agency.

EMA is an agency of the European Union, which has been in operation since 1995, and is headquartered in London. It is the body responsible for the scientific evaluation, testing and safety monitoring of medicines in the EU.

What is EU GMP?

3: Concept of GMP WHO, GMP WHO Standard

3.1: What is GMP WHO

?GMP is part of a quality management system that ensures control of plant (infrastructural) conditions, human conditions and controls Manufacturing processes to meet safety and hygiene standards provide consumers with the elimination of the risk of cross-contamination and confusion.

3.2:GMP WHO Standard

GMP guidelines issued to ensure that medicines, health foods, cosmetics, veterinary drugs are produced stably and controlled in accordance with quality standards suitable for the intended use as well as the regulations of the Company. marketing authorization, while minimizing uncontrolled risks by checking such as cross-contamination, confusion.

Good manufacturing practice involves both production and quality control.

There are many GMP guidelines of many different organizations such as GMP ASEAN, GMP WHO standard, GMP EU, of which GMP WHO is a guideline for good manufacturing practice developed and released by the World Health Organization. was first applied in 1968, is the guideline applied and followed by most of the production facilities in Vietnam.

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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.

3.3: GMP WHO document

gmp file – who

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GMP – WHO standard

4: What is cGMP? cGMP . standard

4.1: What is cGMP

?Another small but important concept is cGMP – (current Good Manufacturing Practice) means current Good Manufacturing Practice. This reminds enterprises that implement GMP, they must use equipment, technology, production processes and scientific information in accordance with the standards at the time of application.

4.2: What is CGMP Standard

?CGMP stands 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 management factors affecting product quality, always ensuring that products meet quality standards and safe.

With the current situation, especially the cosmetic market, it 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

+ HR

+ The machines and equipment

+ Production hygiene, environmental hygiene, personal hygiene.

+ Product quality: prototype

+ Production process: Manipulation of workers, fulfillment of requirements for raw materials, product standards, formulations, physical conditions of production, assessment of supplier’s supply. raw material supply.

+ Check: 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, the CGMP standard is a mandatory standard applied in factories, production workshops, production facilities… to ensure product quality and safety.

5: GMP functional food

Reasons to apply gmp functional foods:

Actively prevent the risk of food contamination during production and processing, creating safe products for users. GMP is a production code, that is, measures and practices to be followed at each stage or part of a stage for each product or group of products, from the receipt of raw materials to the final finished product.

– Meet the trend of food safety management in the world

– Meet the requirements of the integration process and the requirements of the market

– Ensure to produce quality food supplements

– As a tool to:

+ Screening and removing unqualified food production establishments

+ Reduce counterfeit goods, smuggled goods, poor quality goods

+ Building the functional food industry in Vietnam into an economic-health industry, with sustainable and healthy development for the health of consumers.

– Affirming quality and building trust and brand in the hearts of consumers. That is the basis for bringing Vietnamese brand functional foods to the world. At that time, consumers can not only use safe and quality products, but also increase awareness of basic hygiene, increase confidence in Vietnamese goods and improve their quality of life.

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– Help increase consumer numbers, increase government confidence, secure prices, increase competitiveness and marketability, reduce costs for defective products and recalls, improve production processes and the environment. market, improve management capacity to ensure food safety and increase business and integration opportunities.

– Improve public health, improve efficiency and control food safety, reduce costs to public health, facilitate commercial development of the country, and increase people’s confidence in food safety. provide food as well as contribute improve Vietnam’s position in the regional and world markets.

Control all factors related to food safety and quality.

GMP – Functional foods

6: GMP standard in drug manufacturing

– Personnel requirements: For human resources, the requirement is that there should be standards for working positions in order to recruit suitable qualifications and capabilities. Not only that, it is necessary to develop regulations on health checks (physical, mental and illness) of all people, most importantly, direct production workers.

– Requirements on design, construction, installation of houses, workshops and processing equipment: For the pharmaceutical industry, this is extremely important. Enterprises must have regulations on the location of the factory, the design, the type of materials to build the factory, and the appropriate equipment to create quality products.

– Requirements to control factory hygiene and environment: These enterprises need to develop regulations on water treatment used for production, wastewater treatment, treatment of by-products and waste, and environmental sanitation. and factories… This is the premise to produce hygienic products.

Requirements on processing control: Enterprises need to develop regulations on processing methods, procedures, specific work instructions and standards on ingredients, products, and recipes. In addition, there should be measures to check and monitor the production process.

– Requirements on control of product storage and distribution process: Guaranteed production alone is not enough. Enterprises need to set requirements for transportation and storage so that finished products must not be contaminated by physical, chemical, microbiological agents, do not change quality …

GMP standards in drug manufacturing

Through the article below, riclix.com hopes to provide some knowledge about GMP, define GMP standards so that everyone can understand better and in more detail.

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