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" pharmacy is mechanical (equipment) guideline of test and verify " standard par

来源: 作者:Stand originally 时间:2008-12-29 Tag: 点击:
" pharmacy is mechanical (equipment) guideline of test and verify " it is executive drug production the guiding standard that quality management is badly in need of one of normative activity, be badly in need of the account that establish, depend on " management of drug production quality is normative " (GMP) the regulation wants to undertake product and craft test and verify to pharmacy equipment; The 2 test and verify that are pharmacy equipment are becoming medicines and chemical reagents to manufacturing company is measured and evaluate pharmacy machine product quality, order goods and the market of production company product approves way. Be badly in need of the activity of test and verify of equipment of normative inside the industry directive pharmacy, cooperate GMP carry out carry out. Project approving established development of nation of this standard classics and reform committee 2005, the 16th announcement was released 2007, carry out at rising on September 1, 2007. To cooperate to carry out, with respect to the standard main content explains under: 1, the eye ground of pharmacy equipment test and verify and meaning " pharmacy is mechanical (equipment) guideline of test and verify " the standard is to be aimed at medicines and chemical reagents to produce domain and the guiding standard that involve medicines and chemical reagents to produce safe link to put forward, medicines and chemical reagents is a kind of special goods that involves human body health care and cure the sickness to save the patient, the actor bad of its quality matters to the curative effect of medicines and chemical reagents directly, those who matter to people is healthy with life safety, " Pharmaceutical Affairs Law of People's Republic of China " regulation, medicines and chemical reagents produces a business must according to " management of drug production quality is normative " (GMP) constituent production, pharmacy machinery regards medicines and chemical reagents as necessary step of production, having close relationship to the quality of medicines and chemical reagents and safety. Undertook technically formulary in the 7th chapter about GMP of problem of pharmacy equipment test and verify, while GMP thinks pharmacy equipment is producing a measure as medicines and chemical reagents, it is one of contaminative factors that cannot ignore, producing this kind of understanding is to result from management board of American food medicines and chemical reagents (FDA) infusion place is polluted to come in 60 time with respect to Ceng Fasheng startling medical difficult event, be aimed at the investigation that the septicemia case that erupts again and again for a time launchs, the conclusion unexpected that reach, be not is an enterprise did not do asepsis to check or violate medical issue statute, the limitation that checking itself at asepsis however, equipment or the blemish that the system designs and the deviation that produce a course, be like,brought about: Watch and temperature show the pressure on equipment to the need with real position does not agree and did not achieve sterilization to ask; Sealed blemish brings about equipment medicines and chemical reagents gets pollution again; The equipment data impact to medicaments; Equipment of operation method down to is discharged (medicinal powder dirt, medicinal powder hot, waste gas, liquid waste) etc, the design that machines equipment as a result of pharmacy, make, a lot of respects of use link exist possibly the potential risk that causes pollution and alternate pollution, FDA is its reason end " process out of control " , reason puts forward to produce link to have management and the regulation that have test and verify to producing equipment to medicines and chemical reagents, why do this want to use the main reason of equipment test and verify to pharmacy namely, also be distinction lies at general use machinery the argument that accepts monitoring. Although the test and verify of pharmacy equipment is to use what just spread out according to GMP to be purchased about pharmacy equipment reach send the routine work before using, already made the instrument of function of user choice and product of evaluation pharmacy machinery and quality at present, also caused make square mutual the potential competition of a product, the immediate intention of the conforms to put forward with ISO place social responsibility level that the test and verify of equipment yielded an enterprise to find product production and market, this one trends drives the satisfaction of the applicable function that make square consciousness or begins not self-consciously to pay close attention to him product and service to spend, be begun for guidance and normative enterprise and participate in activity of test and verify timely raised guideline of this test and verify make. GMP standard makes clear a regulation: Medicines and chemical reagents produces an enterprise to should undertake product and craft test and verify to pharmacy equipment. Pharmaceutical factory is new purchased equipment is used without reaching what did not pass test and verify to cannot be thrown too, accordingly, the test and verify of pharmacy equipment is mandatory. Although drug production company serves as the dominant of test and verify square, but suffer equipment performance characteristics, operation to experience is restricted and lack the relevant data such as process of test and verify, hope perfectness product function is made with what use just will cooperate test and verify. Square to making for, test and verify is helpful for understanding the use sex of the product, improve function, hurried to send new thinking, begin quality competition. Because test and verify touchs,arrive make, use bilateral profit and make " guideline " pay close attention to bilaterally and be welcomed. 2, the guideline of test and verify of work out basis of guideline of test and verify is a basis " management of drug production quality is normative " (GMP) , JB20067 " the general rule that pharmacy machinery accords with medicines and chemical reagents to produce quality management standard " , " guideline of drug production test and verify " wait for the code with active country and standard, consulted home, outside management of current drug production quality is regular, combine national condition to make. Content of plan of the principle of the term that the standard set test and verify and definition, test and verify, purpose, limits, program, test and verify, test and verify and carry out reach make the technical file material that just should provide, apply to design of pharmacy machinery equipment to affirm (DQ) , installation affirms (IQ) , move affirm (OQ) and function affirm (the guidance that PQ) works. Guideline of test and verify its are main content is what to do in working in the light of test and verify, how be done and make in test and verify, use bilateral responsibility and obligation limit, how make sure test and verify can be effective carry out spread out for the purpose those who write. 3, the principle of overview test and verify of executive test and verify: Test and verify is pharmaceutical factory drops the administrative action before using to equipment, so the pharmaceutical factory of job of test and verify to pharmacy equipment is executive principal part, making just is object relatively. Although test and verify does not have immediate impact with medical engine plant, but the connection with close existence, because medical aircraft company offers the product, final it is to want those who use to sell and be satisfied, want user satisfaction, quality of that is to say still wants an user to comment. Mix from market point of view no matter so international is regular (market liability level) trend, square to making for, test and verify is the means that the product is competed to be evaluated with quality by a kind of cognitive market, from development politic viewpoint needs the participation with medical engine active and active plant test and verify. Ground of eye of test and verify: Requirement of test and verify is right of pharmacy equipment each affirm the activity all wants to have file proof, make the design of pharmacy equipment, installation, move to identify a process to be changed a form to admit really really by control and file really with function. "The file is changed " it is the most important basic method in executive GMP management, it emphasized the traceability of data management, authenticity, make no matter the product evaluated angle to have exact ground from technical administration point of view and product quality. Limits of test and verify: Should according to GMP asks and the condition of the characteristic of pharmacy machinery and pharmacy craft decides. In principle altogethers direct or of medical contacts medicaments, involve all sorts of medicaments character (heat quick sex, adhere sex, hygroscopic, volatile, reaction) , the form of a drug (small pill of agent of velar agent, electuary, suppository, gas mist, infusion agent, tablet, capsule is waited a moment) reach pharmacy, all should belong to the range that must have test and verify. As to specific go to what whether a certain product needs test and verify to limit should according to afore-mentioned by use just press the element such as equipment utility and working medium to decide. Program of test and verify: After the program stipulates equipment enters use place, answer strict according to plan of test and verify, ordinal have design, setup, move to admit really with function, when short of asks, do not undertake falling to confirm the work. 1) the principle that the design affirms to respect design affirms has only, should accord with GMP namely, should accord with use requirement. But when affirming to products plan, use square possibility meeting finalizes the design to having product or new product two kinds of circumstances, to finalizing the design the design of the product affirms, data of level of service of the pitch that examine of main take an examination makes an experience to this kind of equipment, standard that implement, hep GMP, technology, technology and company reputation spread out affirm. And the trial that new product reachs time in the absense of practice, no matter be,use square choice new product to still make research and development of square new product need to be treated carefully. The research and development that this basically depends on new product is existing particular technical risk and market acknowledge, this kind of risk more it is consist in is made square. Accordingly, guideline raised the requirement that new products plan affirms technically, namely: In new products plan development phase is about to try to control, through in mechanical design program " plan is designed " , " the technology is designed " , " working plan is designed " in, executive JB20067-2005 " the general rule that pharmacy machinery accords with medicines and chemical reagents to produce administrative standard " the design quality that mandatory standard will come to assure a product, the doorsill that asks new products plan rises, reduce a risk. Seeing new products plan affirm is to not be equal to affirm at using the design when square product type selecting (affirm beforehand).
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