INSTITUTE FOR STANDARD AND QUALITY DEVELOPMENT STUDIES
10/11/2022
GMP certification is one of the essential certifications that demonstrates a company's capability and credibility while ensuring that products (pharmaceuticals, health supplements, cosmetics) are manufactured with consistent quality, meet regulatory requirements, and provide a safe working environment for employees.
Below, the ISSQ Quality Institute would like to provide readers with information about the basic conditions required for GMP certification.
GMP stands for Good Manufacturing Practices. It consists of general principles, regulations, guidelines, and requirements concerning fundamental production conditions and manufacturing operations.
GMP is also one of the standards used as a foundation for establishing a food safety management system based on the international standard ISO 22000.
Depending on the specific production requirements and standards applicable to a manufacturing facility, the following GMP certifications are available:
GMP certification is applicable to manufacturing and processing sectors that require stringent hygiene and safety conditions, including:
In addition, GMP standards are also highly suitable for application in the food service, restaurant, and hospitality sectors.
GMP standards focus on the following five fundamental elements:
Facility Requirements
Production facilities must be designed and constructed according to a systematic production flow. Different areas should be clearly separated, including raw material storage areas, screening areas, processing areas, packaging areas, and storage areas.
This separation helps distinguish raw materials, semi-finished products, and finished products, thereby preventing cross-contamination among them as well as contamination between food products, chemicals, packaging materials, and printing materials.
Factory Hygiene and Sanitation Requirements
The workspace, tools, and equipment used within the factory must comply with hygiene and sanitation standards.
In addition, supporting sanitation systems such as:
must meet occupational safety and hygiene standards and remain in proper operating condition at all times.
Production Process Control Requirements
Enterprises must establish methods for controlling product quality throughout every stage of production, from raw material screening to packaging and storage.
The hygiene and cleanliness of production facilities must be regularly monitored and inspected to ensure ongoing compliance with required standards.
Employee Health Requirements
Manufacturing and processing facilities must conduct periodic health examinations for employees.
Particularly, workers who directly handle products must strictly comply with hygiene regulations and sanitation requirements.
Product Storage and Distribution Requirements
Finished products must be stored under strict control after packaging.
During distribution from the factory to retail outlets, measures must be taken to ensure that product quality is maintained and does not deteriorate.
According to regulations issued by the Ministry of Health, GMP certification is a mandatory requirement for industries involved in manufacturing and processing products that require high standards of hygiene and safety.
Food Industry
According to Decree No. 15/2018/ND-CP and Circular No. 18/2019/TT-BYT issued by the Ministry of Health, domestic manufacturers of health supplements (functional foods) must obtain a Certificate of Food Safety Eligibility and comply with Good Manufacturing Practices (GMP) for health supplement production.
Imported health supplements must provide equivalent certification demonstrating compliance with food safety eligibility requirements and GMP standards.
Functional Food and Pharmaceutical Industries
Manufacturers of pharmaceuticals and pharmaceutical ingredients are required to implement, publish, and evaluate compliance with GMP requirements in accordance with Circular No. 35/2018/TT-BYT regarding Good Manufacturing Practices for medicines and pharmaceutical ingredients.
The GMP certification applicable to the pharmaceutical sector is the WHO-GMP Certification issued under the standards of the World Health Organization (WHO).
The assessment and issuance of WHO-GMP certification are directly conducted by the Drug Administration of Vietnam and the Administration of Traditional Medicine according to the scope registered by each enterprise.
Cosmetics Industry
According to Decree No. 93/2016/ND-CP, cosmetic manufacturing facilities that have been granted the ASEAN Cosmetic Good Manufacturing Practice (CGMP-ASEAN) certificate by the Ministry of Health are eligible to receive a certificate of cosmetic manufacturing eligibility without undergoing additional licensing procedures required for ordinary facilities.
The above are the basic conditions for obtaining GMP certification.
ISSQ Quality Institute is always ready to accompany businesses throughout their integration and development journey.
Please contact us via hotline: (+84) 981 851 111 or email: vienchatluong@issq.org.vn | tcvn@issq.org.vn. We are honored to serve our valued customers.
Publication Date: November 10, 2022
