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GMP-WHO is a very familiar term, as well as a mandatory standard in the field of pharmaceutical manufacturing. So what is the GMP-WHO standard? What criteria does a pharmaceutical manufacturer that wants to meet the GMP-WHO standard have? Let’s find out with GMP Groups in the article below.

01

What is the GMP-WHO standard?

Pharmaceuticals (also known as medicines) are indispensable products in the prevention, healing, and adjustment of physiological functions of the body.

Due to the direct impact on health, human life, pharmaceuticals in any country are strictly controlled by state management agencies. Accordingly, all laws, circulars and guidelines are geared towards the two most important characteristics of pharmaceuticals: Safety and Quality. To ensure those two characteristics, products must be controlled from the beginning until commercially available. In which the stage of product creation in manufacturing plants plays the most important role. 

The World Health Organization (WHO) has drafted and issued good practice guidelines (GMP) or GMP-WHO standards as a fundamental basis for Member States to apply to control the production of pharmaceutical companies in the country. Many countries, including Vietnam, have used this standard as legal documents to show the mandatory nature of the application of GMP-WHO standards in pharmaceutical production.

For that purpose, GMP-WHO is defined as follows: “GMP-WHO is a guidance system to ensure pharmaceutical products are produced in a uniform manner and in accordance with established quality requirements.” 

02

Advantages of enterprises when applying GMP-WHO standards

In Vietnam, when applying GMP-WHO standards, pharmaceutical manufacturers will have the following advantages:

2.1. GMP-WHO is one of the conditions for being granted a certificate of electrical eligibility for pharmaceutical business, which is understood as a production license.

The state agency will conduct inspections of pharmaceutical companies based on the good practice guidelines of the GMP-WHO standard. Upon meeting the requirements, the enterprise is newly granted a certificate of eligibility for pharmaceutical business to be allowed to produce.

2.2. GMP-WHO is a condition for companies to maintain their pharmaceutical production

The inspection not only takes place at the beginning when issuing “certificates of eligibility for pharmaceutical business” but is also carried out unexpectedly or periodically by state management agencies. If a business does not comply with the GMP standard, based on the level of non-compliance, the production of that business may be stopped.

2.3. GMP-WHO standards help businesses create high-quality, safe pharmaceuticals for humans.

GMP-WHO standards provide guidelines for organization system, quality management, quality review, quality inspection, risk management, factory requirements, equipment, people, document records, production processes … All of these factors are intended to ensure that pharmaceutical production activities are systematic, compliant, and closely monitored, and that the product will be quality assured at all stages/processes without simply checking the final quality of the finished product to ensure the highest safety, The best quality for pharmaceuticals.

2.4. Help to raise the business, increase trust for consumers and partners, thereby increasing revenue and profit.

Because of its legality, the GMP-WHO standard is indispensable when a business demonstrates its ability to take processing orders from partner businesses, or win pharmaceutical tenders into hospitals, as well as distribute pharmaceuticals to dealers, drug sales units.

2.5. Increase the professionalism, discipline of the organization, train the carefulness, compliance of people create its own characteristics: GMP culture, GMP people.

With the requirements in the GMP-WHO standard mentioned above, the GMP-WHO standard helps businesses build a quality management system, a strict, strong process system, constantly improving and improving. There, people are trained very carefully, disciplined, highly compliant thereby creating a professional working environment with the characteristics of GMP.

Mẫu giấy chứng nhận cơ sở đạt tiêu chuẩn “Thực hành tốt sản xuất thuốc”

03

Requirements for pharmaceutical plants meeting GMP-WHO standards?

In order to meet the GMP-WHO standards, pharmaceutical plants must meet the principles and standards of good practice set out in Circular 35/2018/TT-BYT. In this article, GMP Groups asks permission to make the most general and general requirements.

Besides the most basic and important element of GMP is people, technically, the requirement to meet the GMP-WHO standard consists of two parts: Hardware and software. In which hardware is a factory system, machinery and equipment, ancuffer system, software is a process system, document records.

When your business builds both hardware and software well, combined with a trained team of people, your business already meets GMP-WHO standards.

04

GMP Groups - A comprehensive solution provider for GMP-WHO standards

Phòng sạch sản xuất dược phẩm

GMP Groups designed cleanrooms meeting GMP-WHO standards

GMP Groups with a team of many years of operation in pharmaceutical and health food companies understand the nature of GMP’s requirements, understand the difficult obstacles of customers in pharmaceutical production. Therefore, GMP Groups has provided a comprehensive solution to help customers meet and maintain GMP – WHO standards including:

4.1. Cleanroom design and construction consultancy services

This service serves during the construction of the factory.

Design services ensure the correct design of GMP’s principle standards, convenient for customers during the production process.

Construction services ensure accurate, on-schedule construction, regular updates for investors through the visual imaging system.

4.2. Consulting services, supplying production machinery and equipment

Ensure consulting and providing customers with the full equipment system of each line accompanied by a system of assessment and appraisal records that fully meet the requirements of GMP.

4.3. Services to set up document records system, standard operation process

Understanding the document record system, standard operation process in the pharmaceutical factory, GMP Groups will provide customers with the most reasonable and complete set of documents and processes.

4.4. Training services and guidance on operation of quality management system

GMP Groups will help customers train human resources to understand the nature of GMP, guide the customer’s human resources to operate and maintain a good pharmaceutical quality management system.

GMP Groups is committed to a lifetime with customers, committed to ensuring to help customers obtain certificates meeting GMP-WHO standards, supporting customers to overcome the backlog after each inspection and maintenance of the factory during production activities, renovating the factory according to customers’ requirements.

In the pharmaceutical production process, GMP Groups also provides customers with consulting services for preparation technology, helping customers get new, quality and effective products.

Hopefully, the above content will provide some knowledge about GMP – WHO so that people can understand and more detailed about this standard when applied in the pharmaceutical industry. Contact GMP Groups immediately for advice and answers if you are still having questions about GMP-WHO or any other GxP standard. 

GMP Groups Joint Stock Company

Head office: Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province

Hotline: 02203857968 ~ 0972345486

Website: gmpgroups.com.vn

Email: info@gmpgroups.com.vn

0972 345 486