Drug GMP certification process and drug GMP certification of Notes

Drug GMP certification of responsibility and authority

  1.1 State Drug Administration is responsible for national drug GMP certification. State Drug Administration Drug Certification Center (hereinafter referred to as the "Board Certification Center") undertake drug GMP certification of specific tasks.
  1.2 provinces, autonomous regions, municipalities and Drug Administration is responsible for the area of GMP pharmaceutical manufacturing enterprises trial and daily supervision and management certification dossier.


Drug GMP certification
      (Pharmaceutical gmp certification)

Drug GMP certification applications and data review

  2.1 units shall apply where the provinces, autonomous regions, municipalities directly under the drug regulatory department submit "drug GMP certification application", according to the provisions of "drug GMP certification management approach" at the same time submit the relevant information. Provinces, autonomous regions, municipalities directly under the drug regulatory departments should apply from the date of receipt of the information within 20 working days, a preliminary review of the application materials and preliminary opinions and application materials submitted to the State Drug Administration of Safety Supervision Department.
  2.2 Certification application data received by the Bureau of Safety Supervision Department, after formal examination, referred to the Board Certification Center.
  2.3 Board Certification Center received application information, technical review of the application materials.
  20 working days to review comments 2.4 Certification Center Board shall from the date of receipt of the application materials and notify the applicant in writing.

Drug GMP certification program to develop on-site inspection

  3.1 pairs under review by the information unit, on-site inspection program should be developed and reviewed data from 20 working days to organize on-site inspection by the day. Check the contents of the program should include the schedule, check the project, the inspection team members and division of labor. Found in the data reviewed and the need to verify the issue should be included in the inspection range.
  3.2 Board Certification Center is responsible for the on-site inspection notice sent to the unit to be inspected and copied to their local provincial drug supervision and management department, the inspection team members of the unit and the Bureau of Safety Supervision Department.
  3.3 inspection team is generally not more than three people, the inspection team members shall be the State Drug Administration drug GMP inspectors. When the composition of the inspection team, the inspector should avoid this area drug GMP certification inspection.

Drug GMP certification
      (Pharmaceutical gmp certification)
Drug GMP certification on-site inspection

  4.1 site inspection team leader responsible for the implementation of the system.
  4.2 provincial drug supervision and management departments can send one responsible for drug production supervision and management personnel participate as observers in the area of drug GMP certification on-site inspection.
  4.3 Board Certification Center is responsible for organizing GMP certification on-site inspection, and send representatives to attend was the case according to inspection unit to oversee the implementation of coordinated inspection program to assist the head of the drafting of the inspection report.
  4.4 The first meeting include: Introduction inspection team members; Statement inspection precautions; confirm the scope of the inspection; the implementation of inspection schedule; determining inspection accompanying persons. Check the accompanying person must be the responsible person or the production, quality management department, familiar with the pharmaceutical production process, and can accurately answer questions about the issues raised by the inspection team.
  4.5 Inspection Unit shall be in strict accordance with inspection program to inspect the project investigation.
  4.6 comprehensive assessment shall be in accordance with the inspection group to check for defects in the project evaluation criteria to be assessed examination found, make a comprehensive assessment of the results, preparation of reports on-site inspections. During the evaluation summary, the inspection unit should be avoided.
  4.7 inspection report shall be signed by all the staff of the inspection team, along with flaws project, still need to improve aspects of inspector records, issue opinions and objections related information.
  4.8 is not meeting the inspection team presented the results of a comprehensive assessment. The units being inspected can arrange relevant personnel to participate.
  Different opinions and projects for the proper interpretation and evaluation results 4.9 defect inspection unit may be found during the checks, it explained. As contentious issues shall be verified when necessary.
  4.10 inspection found substandard projects and still need to improve aspects of the proposed, after all members of the group shall be subject to inspection and Pijiandanwei Signature, each party holds one.
  4.11 If the problem can not be reached, the inspection team shall prepare records, by all members of the inspection team and Pijiandanwei person in charge after the signing, each party holds one.
   
Audit drug GMP certification inspection reports

  Board Certification Center site from the receipt of the inspection team shall submit the inspection report and the date relevant information within 20 working days audit opinion, sent the State Drug Administration Safety Supervision Department.