Bloomage Secures Global Trust with Comprehensive Compliance, Passing Japan's PMDA Audit and Other International Inspections

16 April 2024 | Tuesday | Regulatory

Demonstrating global compliance, Bloomage successfully passes a comprehensive on-site audit by Japan's Pharmaceuticals and Medical Devices Agency, highlighting its commitment to international quality standards.

Bloomage recently successfully completed the on-site Good Manufacturing Practice (GMP) audit conducted by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). 

As the official regulatory agency for pharmaceuticals in Japan, the PMDA holds significant responsibility for ensuring the quality, safety, and efficacy of medical products and devices.

The outcome of this audit signifies Bloomage's exceptional strength in global quality management, once again acknowledged by an internationally authoritative body.

In addition to the on-site audit by Japan's PMDA, Bloomage has also passed on-site inspections by several important global regulatory agencies, including the US Food and Drug Administration (FDA), South Korea's Ministry of Food and Drug Safety (MFDS), and China's National Medical Products Administration (NMPA). 

Furthermore, the company has obtained multiple international certifications such as ISO 9001, ISO 13485, and ISO 22000, establishing high-standard production lines compliant with US cGMP, China's GMP, and ICH Q7 requirements. Additionally, Bloomage has obtained certifications such as CEP, DMF, KOSHER, HALAL, and VEGAN, further highlighting the widespread recognition of the reliability of its product quality.

Bloomage's emphasis on quality management not only manifests in external certifications but also permeates the core philosophy of the company's development.

The company has established a comprehensive quality management system covering the entire research and development, production, and inspection process. It has established the position of Chief Quality Officer to ensure that products meet rigorous standards from development to market launch.

Bloomage has established five subsidiaries in the United StatesFranceJapanSouth Korea, and Singapore, with business operations covering more than 70 countries and regions worldwide, providing high-quality services to 4,000 pharmaceutical, medical beauty, cosmetics, and food enterprises.

Looking ahead, adhering to the corporate mission of "Creative technology for vibrant life," Bloomage will continue to build its core competitiveness centered on technological strength, product strength, and brand strength. The company will continue to develop raw materials for more high-quality bioactive substances.


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