Why Do Businesses Need GMP Certification?

According to Decision No. 4288/QĐ-BYT, all facilities and enterprises manufacturing and trading health supplements (functional foods) are required to comply with GMP requirements and obtain GMP certification (Good Manufacturing Practices).

According to Clause 1, Article 19; Clause 1, Article 20; and Clause 1, Article 21 of the Law on Food Safety, to achieve GMP standards for health supplements, enterprises must satisfy the following requirements:

• Personnel: Employees must possess the necessary professional qualifications appropriate to their assigned positions and receive basic GMP certification training.
• Facilities and Production Equipment: Factory systems, equipment, and utilities must be designed, constructed, and installed in accordance with their intended use. Equipment must be suitable and capable of minimizing risks and potential damage.
• Quality System Processes and Documentation Control: A quality management system must be established and maintained to control production and distribution activities. Inspection and monitoring measures must be applied throughout the production process to prevent errors, contamination, or cross-contamination.
• Processing Procedures: Specific procedures must be established to ensure that processing activities comply with predefined requirements and maintain food safety and hygiene.
• Storage and Distribution Procedures: Physical and chemical factors (temperature, pressure, humidity, light, etc.) must be strictly controlled to ensure product quality throughout the manufacturing process until products reach consumers.

Basic Conditions for Obtaining GMP Certification

Factory Requirements

The factory must be designed and constructed according to a systematic production flow, with clearly separated areas for product processing (raw material storage area, screening area, preliminary processing area, packaging area, storage area, etc.).

This separation aims to clearly distinguish raw materials, semi-finished products, and finished products, preventing cross-contamination among them as well as between food products and chemicals or packaging and printing materials used during production.

Factory Hygiene and Sanitation Standards

The workspace, tools, and equipment used in the factory must meet safety and hygiene standards.

In addition, sanitation support systems such as water supply and drainage systems, waste collection and storage systems, containers for raw materials, semi-finished and finished products, and personal protective equipment must comply with safety and hygiene standards and always remain in good operating condition.

Production Process Control Standards

Enterprises are required to establish methods for controlling product quality at every stage of production, from incoming raw material inspection to packaging and storage.

The cleanliness and hygiene of the factory must be regularly monitored and inspected to ensure continuous compliance with required standards.

Health Standards for Production Personnel

Manufacturing and processing facilities are required to conduct periodic health examinations for employees.

In particular, workers who directly handle products must strictly comply with hygiene regulations.

Product Storage and Distribution Standards

Finished products must be stored under strict conditions after packaging.

Furthermore, the distribution process from the factory to retail outlets must ensure that product quality is not compromised.

Frequently Asked Questions About GMP Certification

How Many Types of GMP Certificates Are There?

Depending on the specific requirements applicable to production processes and manufacturing facilities, different types of GMP certificates are available:

• WHO-GMP Certificate: Good Manufacturing Practices for pharmaceutical production.
• ASEAN-GMP Certificate: Good Manufacturing Practices for cosmetic manufacturing.
• EU-GMP Certificate: Pharmaceutical Good Manufacturing Practices issued by the European Medicines Agency (EMA).
• PIC/S-GMP Certificate: Good Manufacturing Practices for pharmaceutical manufacturing under the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Which Organizations Are Authorized to Issue GMP Certificates?

Depending on the type of certification (WHO-GMP, EU-GMP, PIC/S-GMP, ASEAN-GMP), certification is granted by different competent authorities:

• WHO-GMP and ASEAN-GMP: Issued by the Drug Administration of Vietnam.
• EU-GMP: Issued by national pharmaceutical regulatory authorities or governmental pharmaceutical agencies of EU member states.
• PIC/S-GMP: Issued by pharmaceutical regulatory authorities that are members of PIC/S.
• GMP certification may also be provided by certification bodies licensed by the Ministry of Science and Technology of Vietnam.

The above information from ISSQ Quality Institute aims to answer common questions regarding the basic conditions required for obtaining GMP certification.

We hope this article provides useful information for you and your business.

ISSQ Quality Institute is always ready to accompany businesses throughout their integration and development journey.

Please contact our hotline at (+84) 981 851 111 or email vienchatluong@issq.org.vn | tcvn@issq.org.vn. We are honored to serve our valued customers.

Publication Date: September 2, 2023