Case Study 29 : Quality Audit and Preassessment before CFDA Inspection for a European CMO

Company Situation

The Client had network of 10+ manufacturing sites in 5 European locations with several development and distribution centers. The Client was due an inspection from NMPA (China Food and Drug Authority) for its freeze-dried vials site in France. Client needed to ensure it was prepared for the NMPA inspection and requested a GMP mock-up audit as per NMPA requirements.

GRP Solution

GRP has significant experience with global Health Authorities and has conducted 500+ audits in over 50 countries globally for various health authorities. GRP’s quality auditors are based in global locations and conduct GMP mock -up audits based to global or country specific regulations. . GRP helped the Client in preparing for the NMPA audit in timely manner using its extensive understanding of Chinese health authority for Client’s audit success.

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China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).