One article read the 2020 version of GMP Appendix 4 "Blood Products" key changes

On July 3, 2020, the official website of the State Drug Administration issued a new revision of the GMP Appendix "Blood Products" release, which will come into effect from October 1, 2020, and the new version of "Blood Products" will contain seven chapters and 35 articles, reflecting the spirit of the "four most severe" and implementing the "Four Most Severe" Vaccine Management Law and "Drug Administration Law" related requirements, further strengthen the management of blood products, regulate the production and quality management of blood products behavior, this article on the new and old version of "blood products" mainly added to the new revision of the content of the article blue font for new or modified content, red font with deleted lines for deleted content, the new and old version of the "blood products" chapter control tableinterpretation: the new version of "blood products" a total of seven chapters 35 articles, the addition of 1 clause, revised 22 articles, unchanged 12 articles, the amendment of the provisions mainly around the further strengthening of blood products management, regulate the production and quality management of blood products behaviorII,2.1 Chapter I Added revision of the content of the comparison tableinterpretation: the new version of "Blood Products" Chapter 1 Scope 4, on the basis of the old version of 4 have been revised, the revised provisions mainly focus on the definition of blood products and regulatory departments and so on2.2 Chapter II The revision of the principles of the comparison tableinterpretation: the new version of "Blood Products" Chapter II Principle 1 clause, on the basis of the old version of the amendment, the revision of the provisions mainly remove the pathogen example2.3 Chapter III The comparison table of the contents of the personnel increase and revision of the contents of theinterpretation: the new version of "Blood Products" Chapter III Person 5 articles, of which 2 articles on the basis of the old version of the amendment, 3 provisions remain unchanged, the revised provisions for the blood products enterprise key personnel (production management and quality management head) qualifications increased academic qualifications, job titles and working years requirements, improve the industry access qualifications2.4 Chapter IV Plant and equipment revision of the content of the comparison tableinterpretation: the new version of "blood products" Chapter IV Plant and equipment 6 articles, of which 2 articles on the basis of the old version of the amendment, 4 provisions remain unchanged, the revised provisions require blood products enterprises to have the enterprise production and quality requirements of the inspection capacityEnterprises should conduct regular laboratory capability assessments to ensure that the results of the experiment are accurate, reliable and true, accurate, complete and traceable in the recording of the inspection process information, thus improving the eligibility of the industry2.5 Chapter V The revision of raw material plasma content control tableinterpretation: the new version of "Blood Products" Chapter V Raw Material Plasma 9 article, which 7 articles are modified on the basis of the old version, 2 articles remain unchanged, the revised provisions around the acceptance of plasma inspection, validity, transportation and destruction management2.6 Chapter 6 Production and quality control revision of the content of the comparison tableinterpretation: the new version of "blood products" Chapter VI production and quality control 9 articles, of which 5 articles on the basis of the old version of the amendment, 3 articles remain unchanged, the addition of 1 clause, the revised provisions around the production management of blood products, the new provisions mainly increased virus pollution and safety management requirements 2.7 Chapter 7 Non-conforming raw material plasma, intermediate products, finished products treatment of additional revision of the content of the interpretation: the new version of "blood products" Chapter VII non-conforming raw material sepulment, intermediate products, finished products treatment of 1 clause, on the basis of the old version has been revised, the revised provisions clearly state that the enterprise is the responsibility of this regulation References