What is GMP Certification?

GMP certification is an abbreviation of the phrase “Good Manufacturing Practices.” In Vietnamese, this term means “Thực hành sản xuất tốt” (Good Manufacturing Practice). When pharmaceutical manufacturing facilities build GMP-compliant factories and satisfy the required standards, they may be granted a GMP certificate by competent authorities such as the Drug Administration and the EMA (European Medicines Agency).

At the same time, GMP is also one of the fundamental standards that supports the development of international standardized food safety management systems such as ISO 22000.

Which Companies Need GMP Certification?

Companies that generally need to obtain GMP certification operate in industries involving the manufacture and processing of products that require strict hygiene conditions, including:

• Food industry
• Pharmaceutical industry
• Cosmetic industry
• Medical device industry

Benefits of Applying Manufacturing Processes in Accordance with GMP Standards

• Standardizes hygiene and safety conditions of manufacturing facilities as well as production activities.
• Helps meet consumer demands and comply with legal requirements related to food safety and hygiene management.
• Builds trust and enhances the reputation of businesses among customers and consumers.
• Strengthens employee confidence, thereby improving responsibility and awareness among managers and workers.
• Enables businesses to proactively organize, establish, and improve production activities according to standardized requirements.
• GMP certification provides support during assessments conducted by regulatory authorities, competent agencies, or other related parties.
• Facilitates product exports to demanding international markets, enhances product competitiveness, and gains recognition from international organizations.
• Expands market opportunities and increases business revenue.

Documents Required for GMP Certification

The dossier serving as the basis for obtaining GMP certification for manufacturing facilities is the application dossier requesting the issuance of a certificate of eligibility for business operations. This dossier is submitted when applying for the certificate of eligibility for business operations. In such cases, manufacturing facilities are not required to submit additional documentation for GMP compliance assessment as prescribed by regulations.

Technical documents relating to the manufacturing facility must be prepared in accordance with the guidance on the Site Master File specified in Appendix VIII, issued together with the relevant regulations, or an updated Site Master File in cases where the scope of operations is expanded.

If a manufacturing facility applies simultaneously for a GMP certificate and a Certificate of Eligibility for Business Operations, it must clearly state this request and specify the GMP principles and standards that will be implemented at the facility in the application form for the Certificate of Eligibility for Business Operations.

When a facility applies for a Certificate of Eligibility for Business Operations, the receiving authority will conduct an assessment of the facility’s GMP compliance in accordance with relevant legal regulations concerning Good Manufacturing Practices.

ISSQ Institute for Quality is always ready to accompany businesses during the process of integration and development.

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: August 4, 2022