Analyze the new GMP top ten highlights

*, the basis for implementing the new version of GMP is honesty and trustworthiness, that is, we believe that you are honest and trustworthy. However, if the drug is found to have false deception in the GMP inspection, it can be judged as unqualified or not passed. The original rule is to assume that you are not honest and trustworthy, and how do I punish you on this basis.

Second, it emphasizes drug production and drug registration and post-marketing supervision. Our current vision can't just focus on your production links within the big wall, but also pay close attention to drug safety.

Third, emphasis is placed on guidance, operability, and checkability. Focus on the guidance, operability and checkability of actual production; clarify specific responsibilities, such as the person in charge of the pharmaceutical production enterprise, the person in charge of production management, the person in charge of quality management, the person responsible for product release, etc. .

Fourth, emphasizing the grasp of principles has increased the adaptability to complex and volatile situations. Most chapters have added a section on principles, including appendices that add to the general principles; highlighting the basic principles that each chapter or appendix must grasp, and provide a basis for scientific assessment of the actual situation of a wide variety of companies.

Fifth, refine the software requirements to make the GMP system more comprehensive, more operational, and avoid ambiguity as much as possible.

Sixth, refine file management and increase the difficulty of illegal operations. In the past, during the reorganization of the registered drug batch number, we mainly found the dishonesty and non-trustworthy problems of the company; this time we put forward specific requirements for the classification of the main documents, which is to be written according to the requirements we have proposed; And the packaging records, have put forward specific requirements, greatly increasing the difficulty of violations in this area, so that companies are not easy to violate regulations.

Seventh, absorb the content of the international advanced pharmaceutical GMP. The basic GMPzui of our country is mainly to follow the standards recommended by WHO for GMP, and then to refer to the standards of the United States and the European Union, and strive to make China's GMP standards reach an internationally recognized level, laying the foundation for international bidding for the procurement of Chinese medicines.

Eighth, inherited the reasonable content of the 98 version of GMP, most of the reasonable terms and frameworks have been retained.

Ninth, introduce or clarify key chapters or concepts. Such as the introduction of quality risk management, supplier audit and approval, change control, deviation processing and other chapters; clear quality attorneys, design confirmation and other key concepts.

Tenth, the terminology chapter has been added to change the ambiguity and difficulty in implementation due to unclear interpretation of some terms.

Mao Zhenbin also said: The new version of GMP will still be classified and implemented in steps. Specifically, since the date of publication, new drug manufacturers and drug manufacturers should establish new GMPs for new workshops; for enterprises that have obtained GMP certificates for drugs, they can be implemented gradually within two to three years after the release of the new GMP. It should be emphasized that the implementation of the revised drug GMP for enterprises undertaking the production of national essential drug catalogue products should be an important reference for bidding enterprises in the bidding and procurement work of various provinces. In addition, we will strengthen the training of GMP inspectors and enterprise technicians.