The Internationalization Trend of GMP and Compliance Development

With the rapid growth of the global pharmaceutical industry, GMP (Good Manufacturing Practice) has become the “passport” for pharmaceutical companies entering international markets. In mature regions such as Europe, the United States, and Japan, GMP is not only a regulatory requirement but also a core measure of competitiveness. Whether in APIs (Active Pharmaceutical Ingredients), finished formulations, or medical devices, companies without GMP compliance capabilities will find it difficult to participate in the global supply chain.

The Value of GMP in a Globalized Context

The World Health Organization (WHO) began promoting the internationalization of GMP as early as the 1960s, followed by ongoing refinements to regulations by authorities such as the U.S. FDA, the European EMA, and Japan’s PMDA. Over the past decade, an increasing number of emerging market countries—including India, Bangladesh, Vietnam, and Laos—have actively adopted international GMP standards to support local pharmaceutical industry upgrades and meet global trade demands.

For example, India’s pharmaceutical exports surpassed USD 25 billion in 2023, with its rapid rise underpinned by the improvement of GMP systems and widespread international certifications. While Bangladesh and Laos are relatively small in market scale, driven by public health needs, both are accelerating GMP facility construction to attract international collaboration and foreign investment.

Chiundo’s Professional Advantages

Chiundo Co., Ltd. has cultivated extensive expertise in GMP consulting and possesses rich hands-on international experience:

Site Selection and Planning: Customized facility planning for pharmaceutical companies in India, Bangladesh, and Laos, based on local environments, regulatory requirements, and logistics conditions.

Factory Design and Equipment Selection: Integrating Japan’s advanced concepts with international standards to ensure production lines meet FDA, EMA, and WHO GMP requirements.

Software Systems and Digital Integration: Introducing LIMS (Laboratory Information Management Systems), ERP, and other digital platforms to enhance quality management and traceability.

Laboratory Integration and Pilot Validation: Assisting clients in establishing internationally compliant laboratories and conducting validation trials to acceleratecertification.

A Bridge for Compliance and International Cooperation

GMP compliance is not only a regulatory threshold but also a key enabler of international cooperation. Through successful implementations in India, Bangladesh, and Laos, Chiundo has developed a comprehensive, replicable, and practical guidance model. This model satisfies local regulatory frameworks while aligning with international audit requirements, providing clients with a solid foundation to enter markets in Europe, the U.S., and Southeast Asia.

Looking ahead, Chiundo will continue to uphold its core values of “Professionalism, Efficiency, and Compliance,” supporting more enterprises in building GMP facilities that meet international standards, thereby driving the globalization of Asia’s pharmaceutical industry.