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The idea that GMP will lead pharmacy company drug production is newer
From;  Author:Stand originally
Nowadays, GMP already was the essential sex system that ensures medicines and chemical reagents is safe, effective acceptedly domestic and internationally. Our country from introduce, brew, arrive to carry out GMP to already had 20 one's remaining years in the round, its hardware must have assuring idea thorough already popular feeling, the importance of its software did not get from beginning to end however enough take seriously. Rose on January 1 from this year, what get attention fully is new " attestation of GMP of medicines and chemical reagents checks criterion for evaluation " already began to apply, new standard strengthened the supervisory examination to business software, refined control of pair of company staff configuration, quality, stock to purchase, the examination project of the respect such as file management, the enterprise that this makes those take workshop, equipment seriously to wait to hardware is built and ignore software to build only hard pass a barrier. Pharmacy business must " soft " " hard " the period that two tactics pays together comes already... well-known, although manufacturing company had obtained GMP letter, but actual level is uneven it is the fact that does not dispute however. Executive standard does not reach the designated position or far-fetched pass a barrier, even the phenomenon of resurgence is not scarce. Besides, with developed country and the difference that current international GMP develops, decided we cannot loosen pursuant pace. Point oneself insufficient point only, continue to increase GMP to carry out strength, initiate sprint to new milepost, ability and international conform. Be worth what carry is, although the pharmacy business of our country experienced the training of GMP attestation mostly, but the former appearance that should replace tradition management from the thought truly reads aloud, accept, comprehend and firm the new concept that establishs GMP, still will be henceforth long-term and formidable task. The idea that GMP leads medicines and chemical reagents production is newer, basically highlight in the following respects. Quality of medicines and chemical reagents of manufacturing quality no risk at all must safe, effective, this are beyond question. However, the unit assures to go up in what cognizance medicine character measures, GMP and traditional manufacturing idea are abhorrent. The quality that GMP place goes after is with each each needle, medicine assure an unit, the purpose depends on realizing no risk at all truly, satisfy the person that use to taste the desire to gain of quality to medicine; And the quality commitment that our enterprise pursues currently just is an unit with approving -- go up objectively, the sampling inspection of medicines and chemical reagents is put in the probability sex with particular move, the quality problem that exists in individual medicines and chemical reagents is not particular can sampling observation arrives, quality of this and medicines and chemical reagents must the GMP target photograph of no risk at all is compared, difference is clearly. GMP concept reflected the biggest liability to the user, and the oneself level that tradition management can reflect a business only. Straight energy of life of the Ceng Li when business of an abroad famous pharmacy is introducing case of their executive GMP is strong the ground says, their product need not leave factory through examining nowadays, because carry out quality of the product after GMP even, effective, final goods inspection just performs a procedure just. A few developed countries are solid to asepsis medicines and chemical reagents inflict " parameter discharged " the product that replaces a tradition examines finally the program of discharged, bring into GMP management. This is the sterilization program that approves with course test and verify in view of them, to asepsis medicines and chemical reagents production has effective quality control, monitored result. The GMP that these in real point falling carries out experience is worth us to draw lessons from. GMP is go up from the concept that ensures medical character measures no risk at all, all sorts of ingredients that produce quality to affecting medicines and chemical reagents raised the basiccest requirement, from go up at all each link that hold influence mass, final implementation produces the no risk at all of quality. Accordingly, executive GMP is one has starting point only and work everlastingly. Realize the mark of GMP, depend on not simply certificate, the GMP certificate of besides our country did not get international accepted. Be in the United States, FDA does not issue GMP letter to the enterprise, because evaluate a company,the standard of implementation GMP should see its product quality whether accomplish no risk at all truly. Obtaining GMP letter is the primary level that executive GMP works only, the GMP demand that home wins card business and our country not less still exists difference also is the fact that does not dispute, we are apart from ultimate goal to still a lot of jobs want to do. The United States from on 60 time begin the century carry out GMP, have new requirement every year up to now, they advocate dynamic " active GMP (CGMP) " , do not do the beautiful frame work that do sth unconventional or unorthodox, emphasize be being carried out continuously. Of course, if one answers originally the working fashionably space of successive becomes from beginning to end two " times " , both neither is exact not appropriate also. Comprehend GMP deeply to start the concept that guide only, search difference and weak point, continual those who deepen GMP carry out, ability explains the essence of GMP truly.

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