What is GMP?

Good Manufacturing Practices (GMP) is a system that ensures products are consistently produced and controlled according to quality standards. GMP is designed to minimize production risks that cannot be eliminated through final product testing.

The main risks include:

• Unintended product contamination that may harm health or even cause death to users;
• Incorrect labeling that does not match registration information submitted to regulatory authorities, potentially misleading consumers about product functions;
• Insufficient or excessive active ingredients, which may affect product effectiveness or cause adverse side effects.

What Types of GMP Standards Exist?

EU-GMP Standard

EU-GMP (Good Manufacturing Practice - EU) certification is issued by the European Medicines Agency (EMA). It is one of the GMP standards responsible for scientific assessment, testing, and pharmaceutical safety monitoring within the European Union.

WHO GMP Standard

WHO GMP is a guideline for good pharmaceutical manufacturing practices developed and first published by the World Health Organization (WHO) in 1968. This standard is adopted and followed by most pharmaceutical manufacturing facilities in Vietnam.

cGMP Standard

Current Good Manufacturing Practice (cGMP) is a standard applied in factories, workshops, and manufacturing facilities to ensure product quality and safety.

What Is the Difference Between GMP and cGMP?

Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (cGMP) are often used interchangeably today.

GMP is the fundamental regulation issued by the U.S. Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act to ensure manufacturers take proactive measures to produce safe and effective products.

On the other hand, cGMP was implemented by the FDA to ensure manufacturers continuously improve their approaches to product quality. It implies a strong commitment to achieving the highest available quality standards through the use of updated systems and technologies.

Five Main Requirements of the GMP Standard

For GMP compliance in the pharmaceutical industry, manufacturing enterprises must fulfill and maintain the following requirements:

Personnel Requirements

Personnel must be assigned and evaluated according to their capabilities and qualifications. In addition, strict regulations regarding health examinations should be established, covering intellectual capacity, physical fitness, and diseases, especially for workers directly involved in production.

Requirements for Factory Design, Construction, and Equipment Installation

Manufacturers must clearly define factory locations and equipment installation areas to ensure operational efficiency and the production of safe, high-quality products.

Requirements for Factory Hygiene and Environmental Control

Input water sources, wastewater treatment systems, by-products, and waste management must be carefully controlled to maintain environmental and factory hygiene. This is a mandatory GMP requirement for pharmaceutical manufacturers to ensure cleanliness and high product quality.

Processing Control Requirements

Enterprises must establish and strictly implement regulations regarding processing methods, procedures, work instructions, raw material standards, technologies, and preparation methods. In particular, monitoring and inspection measures must be maintained throughout the drug manufacturing process.

Storage and Distribution Control Requirements

Pharmaceutical manufacturers must establish storage and transportation requirements to ensure finished products are not contaminated or affected by chemical, physical, or microbiological hazards and that product quality remains unchanged.

Benefits of Applying GMP Certification

Organizations implementing GMP standards can fundamentally and comprehensively improve food safety and hygiene conditions within manufacturing facilities and production activities, thereby meeting legal requirements regarding food safety management.

In addition, GMP provides the following benefits:

• All critical processes are reviewed, developed, approved, and implemented to ensure consistency and compliance with specifications.
• Production conditions, performance requirements, and control measures are clearly identified and defined.
• Production costs are reduced because manufacturing and quality control processes are standardized, and minimum facility and equipment requirements are clearly determined, allowing efficient investment and preventing both overinvestment and inappropriate investment.
• Employee initiative, responsibility, and job understanding are enhanced. Customer and management confidence is strengthened. International recognition is achieved, product brands are protected, competitiveness and marketing capabilities are increased, and business and export opportunities are expanded.
• Products are created through a process that integrates all stages and departments within the manufacturing facility. Therefore, not only must technical specifications in production processes be accurate, but the effectiveness of administrative, human resources, financial, procurement, and sales departments also affects product quality. When every process and department performs according to requirements and maintains quality standards, overall product quality is ensured.
• Controlling and preventing errors or nonconformities from the earliest stages helps minimize product defects, save time and labor resources, increase productivity, and reduce manufacturing costs.
• Proper factory design, production line planning, and equipment installation from the beginning are effective ways to implement GMP successfully.
• GMP serves as a foundation and facilitates the implementation of HACCP and ISO 22000 certification systems.

The above information from ISSQ Institute for Quality provides answers regarding the benefits of applying GMP certification.

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

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

Please contact our hotline: (+84) 981 851 111 or email us at vienchatluong@issq.org.vn | tcvn@issq.org.vn

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Published Date: March 14, 2023