New drugs to complete the assessment revised GMP standards for aseptic improve-G
The latest revised version of the GMP experts focused on refining the software required to make it more operational. In addition to sterile drugs appendix adopted the European Union and the WHO latest A, B, C, D grading standards, and the cleanliness level put forward specific requirements, hardware requirements for the production of other drugs in this revision has not changed.
HC pharmaceutical industry network Revised version Drug GMP expert assessment of feasibility studies have been completed, this revised GMP standards focus on detailed software requirements, on the other pharmaceutical production hardware requirements have not changed, but the sterile pharmaceutical standards have greatly improved.
"The current revised version of an expert assessment of pharmaceutical GMP demonstration has been completed and is being concluded and summarized, then submitted to the State Council, or to form an opinion.
"Recently held in Shanghai," China? World Medical Forum ", the State Food and Drug Administration safety expert supervision of the Secretary says.
Learned that the argument is a comprehensive evaluation of the work of the major criteria for enterprises produce a revised version of the pros and cons, but the revised terms on temporarily modified. The latest revised version of the GMP experts focused on refining the software required to make it more operational. In addition to sterile drugs appendix adopted the European Union and the WHO latest A, B, C, D grading standards, and the cleanliness level put forward specific requirements, hardware requirements for the production of other drugs in this revision has not changed.
Sterile drugs increased hardware requirements
It is understood that this amendment involves the basic requirements and GMP sterile drugs, herbal preparations, bulk drugs, biological products and blood products in Appendix 5. Version of the original 98 in the non-sterile pharmaceutical GMP requirements into Appendix basic requirements. Sterile drugs is greatly improved because of the standard, related companies may need to carry out some necessary hardware inputs.
98 version due in the Chinese Herbal Medicine GMP, radioactive pharmaceuticals, medical gases Appendix time being revised and will continue to use, incompatible with the new version of GMP compliance of the new version. Then, for the implementation of the pharmaceutical companies will have a basic requirement of GMP, a new Appendix 5 and Appendix 3 of old. Appendix
biological products, the new GMP production of biological products according to the characteristics, with emphasis on production technology and strict control of the middle of the process and to prevent pollution and cross-contamination of a series of demands, to strengthen the production management, especially in seed lots, cell bank system management requirements and production operation and the specific requirements of raw materials. Appendix
blood products is a new version of GMP Annex, with a focus is to ensure that raw plasma, intermediate products and finished products, the safety of blood, plasma re-examination of the raw materials, quarantine period set for the plasma member information and product information retrospective, intermediate and finished products testing security index, in vitro diagnostic test reagent management, feed production, inactivated virus, failed in all aspects of plasma processing, specifically to ensure that raw materials on the plasma, intermediate products and finished products safety specific requirements. Chinese Herbal Preparations Appendix
reinforced quality control of TCM Preparation, extraction process control, extract storage management, preparation of Chinese medicine and Chinese medicine quality control program, the recovery of solvent extraction in the control fully the requirements put forward.
In addition, raw material mainly based on the revised appendix of ICH Q7, the deletion of the Q7 in duplicate content with the basic requirements for the retention of the special requirements for bulk drugs. Appendix enhanced API software requirements, an increase of classical fermentation process control standards, clear recovery of raw material medicine, rework and re-processing of the specific requirements.
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