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On-site GMP Auditing & Training for Oversea Pharmaceutical Company


At the invitation of one pharmaceutical company who produce injections, PHDS expert group has made an on-site GMP auditing and training program from September 21 to September 24 2015. Throughout the on-site auditing in warehouse (API, formulation and packages), API workshop (dynamic production), formulation workshop (dynamic & static states), purified water system, water for injection (WFI) system, air-conditioned system, QC lab and document management, PHDS has made a comprehensive guidance on CFDA’s on-site auditing procedure, regulatory requirements and updated GMP regulations. In the 4 days work, our expert group has indicated over 40 corresponding comments and suggestions for correction. It is great important to the oversea pharmaceutical to get through CFDA on-site GMP inspection and auditing.