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China's pharmaceutical GMP revision work is stepping up. The revised GMP has refined the software requirements, focused on the improvement of the software level, and strengthened the link between GMP and drug registration and post-market supervision. The draft version of the new version of the drug GMP consultation will be released early next year and it will solicit opinions from the community. This is what the reporter learned from the 2008 International GMP Forum held by the State Food and Drug Administration on December 8-9.
The GMP revised draft of the drug adheres to the principle of “safety, effectiveness, and controllable quality.†The focus is on refining software requirements to make it more maneuverable and avoid ambiguity as much as possible. Except for the aseptic pharmaceutical production plant produced by the aseptic process, the hardware requirements for the production of other drugs have not changed in this revision. The revised GMP strengthens document management, highlights the focus of GMP, and introduces or defines concepts such as drug quality rights holders, design verification, change control, and deviation handling. At the same time, on the basis of drawing on and referring to the advanced international GMP standards, taking into account the national conditions and absorbing the current regulatory experience. For example, according to China's experience and lessons in the implementation of GMP in the past, some key contents such as suppliers' audits and approvals, change control, and deviation processing have been added in order to strengthen the control and management of related links by domestic enterprises. In addition, some of the standards or requirements that are required to be adhered to over a long period of time, such as supplier quality audits, drug release audits, plasma management, virus removal, or inactivation, have been adopted.
The revised drug GMP also strengthened the link between GMP and drug registration and post-market supervision, and matched relevant requirements with the requirements of the latest “Drug Registration Regulations†and “Medicine Recall Management Regulations†and strengthened the registration requirements for drugs. The strict implementation of the pharmaceutical production chain rationalized the relationship between drug production supervision and drug registration supervision. In addition, the regulatory requirements for post-marketing drugs have also been greatly increased. For example, companies must review product quality reviews on an annual basis and conduct ongoing product stability inspections. According to the GMP standards of the World Health Organization, the specific requirements for drug recalls were refined, and it was clearly proposed that the pharmaceutical production companies should be responsible for executing product recalls and balance the quantity of recalled products, prompting the enterprises to continuously pay attention to the quality of products after the listing.
This revision refers to the relevant GMP standards of the World Health Organization, the U.S. Food and Drug Administration and the European Union. The amended GMP General Regulations consist of 15 chapters, 53 clauses, and 328 clauses, totaling approximately 34,000 words. This article describes the quality of pharmaceutical production in a complete and detailed manner. The regulatory requirements for all medicines.