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The inspectors carried out a comprehensive inspection at both the R&D site and manufacturing site of Chime Biologics on the product process development, technology transfer, process scale-up, process characterization and process validation, etc. All met the requirements. The inspectors also comprehensively audited Chime Biologics’ computerized system for data integrity. All data was authentic and valid without any data integrity issues. The inspectors also inspected Chime Biologics’ organization and personnel; facilities/utilities and equipment; material management; production management; quality assurance and control; and other programs such as complaints and recalls; self-inspection, etc. The inspections had no critical or major observations, and the inspectors gave a high evaluation rating to Chime Biologics’ quality management system. The inspection concluded that the manufacturing condition of Chime Biologics conformed to the GMP requirements and completely had the ability for commercial manufacturing.
Dr. John Zeng, the Chief Executive Officer of Chime Biologics, commented: “We are very pleased that we have successfully passed the inspection by the National Medical Products Administration, which not only marks that the quality management system of Chime Biologics has reached the commercial manufacturing level, but also that we have achieved an important milestone in the strategic objectives of the Company. Taking this inspection as the starting point, with a perfect quality system and deep understanding of GMP regulations as the support, as well as a flexible manufacturing supply chain and increasingly expanding manufacturing capacity as the assurance, the Company will persevere in providing high-quality services to energize global customers, firmly implementing our commitments and helping global partners accelerate the marketing process of innovative products, in order to benefit the majority of patients.”
- Chime Biologics received and passed the on-site inspections of drug registration and drug GMP compliance in December 2021 and January 2022, respectively, which convincingly demonstrated that Chime Biologics’ manufacturing platform and quality system are highly conforming to data integrity and GMP compliance.