Since July 1, 2004, all pharmaceutical preparations and raw materials in China have achieved production under GMP conditions, and the implementation of pharmaceutical GMP has achieved major phased results. This has played an important role in ensuring the safety and effectiveness of public drug use and promoting the healthy development of medicine. In order to do a good job of implementing GMP for other types of drugs, supplementary provisions on GMP for traditional Chinese medicine decoction pieces and medical gases were issued on January 30, 2003. The certification pilot began in June 2003. At present, the work is progressing smoothly and some experience has been accumulated, which has laid a good foundation for the full implementation of GMP.
The application enterprise shall submit the certification application and declaration materials to the acceptance hall of the provincial Bureau
Examination of the form of application materials by the Drug Safety Supervision Department of the Provincial Bureau (5 working days)
Certification Technical review of the application materials (10 working days)
Certification of on-site inspection plan (10 working days)
Provincial Bureau approval plan (10 working days)
Certification organization to conduct on-site certification inspection (10 working days)
Certification Initial review of site inspection report (10 working days)
The provincial Bureau will review and approve the opinions of the preliminary certification (10 working days)
Report to the National Bureau for announcement of review (10 working days)
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Copies of Drug Production License and Business License of Enterprise Legal Person
Self-examination of drug production and quality
Organization chart of drug production enterprises
Resume of person in charge of pharmaceutical manufacturing enterprise and department head; Pharmaceutical and related professional and technical personnel registration form, engineering and technical personnel
Registration form, registration form for skilled workers; Proportion table of middle and junior technical personnel
Grass Jinghua Traditional Chinese Medicine slices production variety table (including processing scope, according to standards and quality standards)
A map of the surrounding environment of the drug manufacturing enterprise; General layout plan; Storage floor plan; Quality inspection site layout
General situation and layout plan of workshop of pharmaceutical production enterprise; Air supply and exhaust layout; Plane layout of process equipment