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