Case Study 45: GMP Mock Audit for China NPMA Pre-approval Inspection

Company Situation

The client is a large pharmaceutical US based company that was in a process of registering one of its new drugs in China. The new drug is a controlled substance used for the treatment of severe pain. Its manufacture, supply, delivery and follows very strict regulations for controlled substances.  As part of the drug registration process in china, China NPMA has to conduct a pre-approval GMP inspection of the manufacturing site in USA before approving the marketing authorization of that drug in China.

As the company has no experience with Chinese NMPA inspection process, and didn’t want to fail such inspection, it requested GRP to conduct for a GMP Mock-up audit of its manufacturing in USA according to Chinese GMP regulatory and quality requirements.

GRP Solution

Global Regulatory Partners has a strong team of certified GMP quality auditors globally, who can perform different GMP quality audits including mock-up GMP audits that prepare companies for health authorities  such as FDA, NMPA, PMDA, Anvisa, TGA , pre-approval inspections  that take place during the review of the application for the registration of a new drug…

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