New version of the drug GMP public solicitation opinion
stake online sports bettingstake online sports bettingRelease time: 2009-10-22 & nbsp & nbsp & nbsp Source:
Recently，The State Food and Drug Administration publicly solicited opinions on the "Specification of Drug Production Quality Management" revised，Solicitation time for comments as of November 30, 2009。
It is understood，This revised drug GMP，Focus on refer to the drug GMP recommended by WHO，The overall idea is to strengthen software construction，Implement "hardware important、Software is more important、The most important quality management concept of personnel。The revised drug GMP includes basic requirements and 5 appendix (sterile medicine、APIP、Biological Products、Blood Products、Traditional Chinese Medicine Preparation)，Among them, there are 15 chapters of the basic Stake Sports Bettingstake online sports bettingrequirements、324 items。1998 Edition of GMP's Non -aseptuous Drug Appendix Requirements Requirements merged into the basic requirements。
The revised drug GMP has greatly improved the requirements for the quality management software of the enterprise，Control and management of the key links of reinforcement drug production。At the same time，Added the terms and content of the quality requirements of drug production and management personnel，Further clarifying responsibility。13443_13467，The person in charge of production management、The person in charge of production management、Quality Management person in charge、Drug quality authorities, etc., must have the qualifications and responsibilities that should be fulfilled。In stake betting appaddition，stake online sports bettingFocus on ensuring the quality and safety of drugs，Software for some high -risk varieties、Hardware proposed new requirements。such as，Improve the cleanliness level of the production of sterile drugs，Using the latest A of the European Union and WHO、B、C、D grading standard，Improve the quality assurance level of sterile drugs。
