How to Achieve End-to-End Implementation of a GMP-Compliant Facility

For pharmaceutical companies, core competitiveness lies not only in R&D capabilities but also in a stable, compliant, and scalable production system. The construction of a GMP facility is a complex and systematic process, covering site selection, design, construction, equipment selection, software integration, and quality validation. Every stage directly determines whether products can successfully enter international markets.

Five Key Stages of GMP Facility Construction

1. Site Selection

A site must balance environmental protection, logistics, raw material supply, and workforce conditions, while also meeting local regulatory requirements specific to pharmaceutical facilities. For example, in Laos, where the government enforces strict regulations on environmental emissions in the pharmaceutical industry, Chiundo supports clients early in the project by conducting compliance assessments and feasibility studies for site selection.

2. Facility Design

GMP regulations provide clear requirements for plant design, including the separation of production, storage, and testing areas, as well as distinct personnel and material flow pathways. By integrating Japan’s advanced GMP concepts, Chiundo helps clients in India and Bangladesh develop scientific layouts that minimize the risk of cross-contamination.

3. Equipment Selection

Market orientation varies by country. If the target market is the U.S. or Europe, equipment must meet CE and FDA certification standards. For Southeast Asian markets, companies may balance cost considerations by combining local equipment with select imported machinery. Chiundo creates “tiered configuration” plans for clients to maximize return on investment.

4. Software and Digital Systems

In the era of digital compliance, hardware alone is not sufficient to pass international audits. Chiundo assists clients in implementing systems such as LIMS (Laboratory Information Management Systems), MES (Manufacturing Execution Systems), and ERP platforms. These systems enable full-process traceability and electronic compliance, meeting the requirements of FDA 21 CFR Part 11 for electronic records and signatures.

5. Laboratories and Validation

Laboratories are a core component of GMP facilities. Chiundo guides clients in establishing internationally compliant microbiology labs, quality control labs, and stability testing labs. The company also supports pilot production and validation processes, accelerating factory certification.

Chiundo’s International Implementation Cases

India: Guided the construction of an API facility targeting exports to the U.S. and Europe, successfully passing WHO GMP inspections.

Bangladesh: Assisted a local company in building a formulation plant from the ground up, enabling the first batch of medicines to be exported to Southeast Asia.

Laos: Supported the creation of the country’s first modern GMP facility, improving public health capacity and establishing a regional pharmaceutical export hub.

Chiundo’s Conclusion

GMP facility construction is not about isolated breakthroughs—it is a system-wide project. With its end-to-end approach and cross-border expertise, Chiundo Co., Ltd. helps clients achieve a full transformation—from the ground up, from compliance to international certification.