INSTITUTE FOR STANDARD AND QUALITY DEVELOPMENT STUDIES
19/04/2024
According to Government Decree No. 15/2018/NĐ-CP, issued on February 2, 2018, when declaring products belonging to the health supplement category, a Certificate of Food Safety Eligibility that complies with Good Manufacturing Practices (GMP) is required for domestically manufactured health supplements. This requirement has been applicable since July 1, 2019 (certified copy provided by the organization or individual).
Therefore, obtaining a GMP certificate is a mandatory condition for pharmaceutical and health supplement manufacturing facilities to continue production while enhancing the reputation of both their products and businesses. So, what is GMP certification? Let’s explore this topic with the ISSQ Institute for Quality through the article below.
A GMP certificate is one of the essential certifications that demonstrates a company's competence and credibility while ensuring that products (pharmaceuticals, health supplements, and cosmetics) are manufactured consistently in quality, meet specified requirements, and ensure workplace safety for employees.
To obtain GMP certification, businesses should seek reputable GMP consulting and training companies as well as reliable certification bodies. It is also important to understand how to distinguish genuine GMP certificates from fraudulent ones. Companies should know how to obtain GMP certification and understand the GMP certificate format and requirements.
According to Decision No. 4288/QĐ-BYT, all facilities and enterprises involved in the production and trading of health supplements (functional foods) must meet GMP requirements and possess a GMP certificate before being considered for approval.
According to Clause 1, Article 19; Clause 1, Article 20; and Clause 1, Article 21 of the Food Safety Law, businesses manufacturing health supplements must satisfy the following GMP requirements:
Employees must possess professional qualifications appropriate to their assigned positions and receive basic GMP training.
Factory systems, equipment, and utilities must be designed, constructed, and installed according to their intended purposes. Suitable equipment helps minimize hazards and risks of product damage.
A quality management system must be established and maintained to control production and distribution processes. Inspection and monitoring measures should be implemented during production to prevent errors, contamination, or cross-contamination.
Specific processing steps must be established to ensure compliance with regulations and maintain food safety and hygiene.
Physical and chemical factors such as temperature, pressure, humidity, and light must be strictly controlled to maintain product quality from production through delivery to consumers.
The Directorate for Standards, Metrology and Quality issued Decision No. 05/1997/TĐC, providing general guidance on the fundamental contents of GMP standards applicable to food manufacturing establishments.
The Ministry of Health issued Decision No. 3886/2004/QĐ-BYT, implementing the principles and standards of “Good Manufacturing Practices for Pharmaceutical Products” according to the recommendations of the World Health Organization (WHO).
In the same year, the Ministry of Agriculture and Rural Development issued Decision No. 08/2004/QĐ-BNN-TY dated March 30, 2004, implementing the principles and standards of “Good Manufacturing Practices for Veterinary Medicines.”
The Ministry of Health issued Decision No. 05/2008/QĐ-BYT, requiring traditional medicine manufacturers to apply GMP standards similar to those applied by modern pharmaceutical manufacturers.
The Ministry of Health issued Circular No. 02/2016/TT-BYT, regulating the application of GMP to health supplements.
The Government issued Decree No. 15/2018/NĐ-CP, stipulating that from July 1, 2018, health supplement manufacturing facilities must apply GMP standards for health supplements in accordance with Ministry of Health guidelines.
In particular, manufacturers are required to apply standards such as GMP, HACCP, ISO 22000, and others in food production and food safety management.
GMP certification is applicable to manufacturing and processing sectors that require high standards of hygiene, including:
In the food industry, restaurants and hotels are also encouraged to implement GMP certification.
All critical processes are reviewed, documented, approved, and implemented to ensure consistency and compliance with specifications.
Production conditions are established, and implementation and control requirements are clearly specified.
Costs are lowered through standardized production and quality control processes. Minimum requirements for facilities and equipment are clearly defined, enabling effective investment decisions, preventing unnecessary expenditures, waste, or investments that do not serve their intended purpose.
GMP enhances employee initiative, responsibility, and job understanding while increasing trust from customers and regulatory authorities.
Businesses gain international recognition, protect product brands, improve competitiveness and marketing effectiveness, and increase opportunities for business growth and food exports.
GMP facilitates the transition from independent inspections to recognition and mutual acceptance, supporting international integration and meeting the requirements of importing markets.
The above information explains why businesses should apply the GMP standard.
The ISSQ Institute for Quality is always ready to accompany businesses throughout their integration and development journey.
For assistance, 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: April 19, 2024
