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Good manufacturing practices (GMP) are one of the sets of principles and standards to be ensured for pharmaceutical production facilities. In the trend of global integration, Vietnamese production facilities not only need to meet domestic requirements but also comply with the requirements of other regions and territories such as GMP-EU, GMP-WHO, GMP-Japan standards. In this article, let’s find out what the GMP-EU standard is. How is GMP-EU different from GMP-WHO?

01

What is the GMP-EU standard?

GMP-EU is the guidelines governing the rules governing drug products within the European Union, including guidelines that explain the principles and guidelines of good manufacturing practices for human and veterinary drug products.

Currently GMP-EU is the highest standard applied in good pharmaceutical manufacturing practices.

tư vấn tiêu chuẩn GMP EU

EMA – European Medicines Agency

 

02

Key topics in the GMP-EU standard

Basically the key topic in GMP-EU does not differ too greatly from other pharmaceutical GMP standards including:

a) Quality management system

b) Document dossiers

c) Computerized system

d) Data integrity

e) Personnel requirements and training requirements

f) Risk assessment

g) Appraisal and evaluation

h) Quality control

i) Responsible person and export

j) Supplier reviews

k) Reviewing leaders

Some topics are very preferred by GMP-EU inspectors such as data integrity; micro-refining system; Risk management and leadership review. These are more difficult and less compliant topics because pharmaceutical businesses are adopting GMP-WHO.

03

What is the similarity and difference between GMP-WHO and GMP-EU?

3.1. Similarity

GMP-WHO and GMP-EU are both good manufacturing practices applied in the field of pharmaceutical manufacturing. In it:

GMP-WHO is drafted and promulgated by the World Health Organization. GMP-WHO is currently used in more than 100 countries, mainly developing countries.

GMP-EU is drafted and issued by the European Medicines Regulatory Authority (EMA). This standard applies exclusively to member states of the European Union. GMP-EU compliance at companies outside the European Union (EU) when certified by a competent authority of the EU member state is seen as a guarantee for the production of safe and quality drug products.

– All are built on the basis of ISO 9001 in establishing a quality management system. With the same view:

“Good management practices in all processes will lead to guaranteed product quality and customer satisfaction” rather than merely checking the final product quality. Product quality is an indirect result in the effective implementation of the quality management system.

Phòng sạch nhà máy sản xuất dược phẩm tiêu chuẩn GMP EU

GMP EU Standard Pharmaceutical Factory CleanRoom

3.2. Differences

With the continuous improvement in the system of guidelines, GMP-WHO standards are increasingly enhanced. Currently, theoretically the difference between the GMP-WHO system and GMP-EU is getting smaller and almost equivalent.

The GMP-EU guidelines are not as detailed and specific as GMP-WHO but when applied in practice always require a high level with the expectation that the best standard will be implemented.

GMP-EU focuses more deeply on the following:

+ Control infection and cross-contamination

+ Supply chain control: API provider rating

Stricter control over excipience.

For other GMP themes, the biggest difference is the implementation and mandatory application to production practice.

04

What are the advantages of enterprises when applying GMP-EU standards?

As mentioned, GMP-EU is one of the highest standards of manufacturing good practice today in the world. Being granted a GMP-EU certificate by the competent authority of the ema participating country will bring many advantages to pharmaceutical manufacturers including:

Manufactured drugs are guaranteed quality and safety with a high level, bringing greater trust to customers and users.

GMP-EU requires strict compliance, mandatory application of good production practice guidelines in practice. Therefore, the production process is more closely monitored and assured.

– GMP-EU requires and encourages the investment and use of modern machinery and equipment lines, scientific and technological advances in production practice. As a result, the product is of high quality.

GMP-EU has tighter control over infection and cross-contamination, a deeper assessment of the supply chain as well as tighter control over excipience. As a result, the quality of the product is controlled in more detail from the original raw materials and excipience to the production process of the product.

Increase the opportunity to enter foreign markets, the opportunity to receive processing orders, the opportunity to receive technology transfer.

– Partners and customers will have high trust in GMP-EU-standard businesses. Especially foreign customers and partners.  

Meeting GMP-EU standards helps businesses export their pharmaceuticals to other countries around the world, even the most demanding markets such as the US, Europe, Japan and Australia.

– This is also a condition for businesses to receive great attention from foreign pharmaceutical companies. Thereby having the opportunity to produce the highest quality and most superior drugs through the form of technology transfer, exclusive partners …

GMP-EU-standard enterprises will gain an advantage in bidding for drugs into medical facilities.

According to circular No. 15/2019/TT-BYT, achieving GMP-EU will help businesses gain priority when bidding for different generic drug groups. It is also one of the motivations for pharmaceutical enterprises to increasingly invest in the development of GMP-EU standards.

05

GMP Groups advises on the development of GMP-EU standards

5.1. Advantages of GMP Groups in GMP-EU standard development consultancy

GMP Groups with a team of personnel with many years of operation in pharmaceutical companies built according to GMP-EU standards; Have worked with foreign partners and experts in the construction of GMP-EU. GMP Groups is confident to bring businesses with the best GMP-EU standard construction consultancy needs with the following advantages:

+ Understand the principles of designing and building factories as required by GMP-EU.

+ Understand the requirements of auxiliary systems: HVAC, water, pneumatic as required by GMP-EU.

+ Understand the requirements of production machinery and equipment, testing at the request of GMP-EU.

+ Understand the requirements of the system of documents, evaluation and appraisal, training … At the request of GMP-EU.

5.2. GMP-EU cleanroom package service

In addition to gaining expertise in GMP-EU, GMP Groups also provides customers with integrated services including:

a) Cleanroom design and construction consultancy services

– Design service ensures the design in accordance with the principle standards of GMP-EU, convenient for customers in the production process.

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

b) Consulting services, supplying production machinery and equipment

Ensure consultation and provision to customers the full equipment system of each line accompanied by a full system of assessment-appraisal records that meets the requirements of GMP-EU.

c) Guidance services for establishing documents and procedures to meet GMP-EU standards

Understanding the system of documents and procedures in pharmaceutical manufacturing plants according to GMP-EU standards, GMP Groups will provide customers with the most reasonable and complete process system and document records.

Đội ngũ chuyên môn tư vấn hệ thống quản lý chất lượng của GMP Groups

GMP Groups’ quality management system consulting team

d) Training services and guidance on operation of quality management system

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

GMP Groups commits to a lifetime with customers, supporting customers to overcome the backlog after each inspection and maintenance of the factory during production activities, renovating the factory according to the customer’s 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.

For more information on GMP EU CleanRoom Design Consultancy – Training – Guidance on Applying GMP EU please contact: 

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