Currently, factories producing drugs, health food, cosmetics, and cosmetics require strict quality requirements. Therefore, the certificate of GMP is a necessary condition for the plant to operate. Join us to learn more about this type of certificate!
1. What is GMP certification?
GMP stands for the initials of the phrase "Good Manufacturing Practices". When translated into English this phrase means "Good Manufacturing Practice". When drug manufacturers build their factories meeting GMP standards and meeting the set standards, they will be granted the GMP certificate by competent agencies (Drug Administration of Vietnam, EMA ...).
At the same time, this is also one of the basic standards for the development of the ISO 22000 international standardized food safety management system.
2. What types of companies need GMP certification
GMP is applied in the fields of manufacturing and processing products requiring high hygienic conditions such as:
- Food
- Medicine
- Cosmetic,
- Medical equipment.
- In the field of food, restaurants, hotels are also very suitable for applying GMP
In Vietnam, according to the decision of the Ministry of Health, GMP standards are compulsory standards applicable to all food production, processing and trading establishments.
3. Basic conditions for obtaining GMP certification
Requirements for workshops: Must be designed, built according to the sequence system of the production line, clearly dividing the zones to hang the product processing process (input area, screening and processing area variable, packaging, storage ..). In order to clearly divide raw materials, semi-finished products and finished products, prevent cross-contamination between them, as well as between food and chemicals, materials used in packaging printing ...
Standards of factory hygiene and safety: Space, tools, equipment used in factories ... need to meet hygienic safety standards. At the same time, sanitation service systems such as water supply and drainage systems; Waste conduction system; Tools containing raw materials, semi-finished products and finished products; Labor protection equipment ... must meet safety standards and always be in good working condition.
Production process system control standards: Requiring businesses to have a quality control method of products in each production stage (From input material screening to packaging and preserving Products). Monitor and check the sanitary quality of the factory to ensure the factory always meets the standards.
Workers' health standards involved in production: It is imperative that the production and processing establishments conduct periodic health checks for employees. Especially for those who work directly with the product must comply with the regulations on hygiene.
Standards for product storage and distribution: The finished products after being packed need to be strictly preserved. At the same time, the process of product distribution from the factory to the wholesale and retail establishments should ensure product quality without deterioration.
4. Types of GMP certification
Depending on the different conditions of the production process and factory standards, there are different types of GMP certificates:
Certificate of WHO-GMP.
Certificate of ASEAN-GMP.
EU-GMP certificate.
Certificate PIC / S-GMP.
5. The units are entitled to issue the GMP certificate
Depending on the type of certification (WHO-GMP, EU-GMP, PIC / S-GMP, ASEAN-GMP) will be issued in different authorities:
WHO-GMP, ASEAN-GMP: issued by the Drug Administration of Vietnam
EU-GMP: issued by the pharmaceutical regulatory authority of other countries or the pharmaceutical regulatory authority of the EU member states.
PIC / S-GMP: issued by a competent pharmaceutical authority that is a member of the PIC / S.
Hope the above information will help you better understand the GMP certificate. Refer now to make sure the factory unit you are choosing is safe or not. Also, if necessary, apply for a certificate for your factory right away!
