European Union this second edit the main principle that GMP standard holds to is: The holder of production license must be made ensure suit to expect use, accord with appear on the market make claimable drug, because security, quality or effectiveness are insufficient,cannot wait for a problem and patient park risk in. Want to achieve this one goal, must have an integrated design and the system that implement correctly, want integrated medicines and chemical reagents to produce guarantee system of control of quality management standard, quality, quality and quality risk to run a system. Can see, the principle runs quality risk the system to be put in the position with manage a standard to wait coequal and significant with manufacturing quality. This is this second edit the markeddest change.

Change is material system added an appendix now 20 " quality risk manages " . Introduce quality risk management GMP guideline, represented henceforth direction of castigatory of European Union GMP. "The GMP previously does not have the concept of risk management in the guideline, to get used to an appendix the requirement of 20, this advanced word all added this one idea with the first chapter. " Sun Yue makes the same score an analysis to, henceforth of the guideline individually paragraphic with the appendix, will make around this concept edit accordingly, evaluate zephyr danger in order to reflect a risk to control.

As we have learned, the GMP concept previously is to be based on test and verify, rely on file and record, means is relatively formalist. Nowadays, euramerican each country introduces a risk to control a concept in succession, want to be able to prove do not have a risk only in be carried out actually, so, fall without fluctuant circumstance in the file, the enterprise need not be carried out according to the requirement of the file, be helpful for innovate and developing.

Additional, in editing, adjust bigger still have an appendix 1 in about part of asepsis medicines and chemical reagents (point to injection and freeze-dry pink injection) regulation, outfit of the production to this kinds of medicines and chemical reagents, preparation, canister, heal, dozen the link such as the lid and manufacturing area are clean degree waited to all make more detailed provision. Introduce according to personage of know the inside story, specific target is adjusted not quite, some was increased a little a few, some key are a few lower, but the literal demand of the management to clean area and monitoring increases to from 6 original 20. "The requirement is more meticulous, more specific. " and about biological product and biology technology, medical the long emend of aeriform field content is in in seeking an opinion.

The message says, of GMP guideline the process that editing is an advance gradually, each clause carries out time each are not identical. Among them, quality risk management already was carried out at rising on March 1 this year, the new regulation that asepsis medicines and chemical reagents produces will rise on March 1, 2009 carry out, other part criterion postpone comes carry out before March 1, 2010. Dcl
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