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| The full implementation of the medical GMP is not up to standard or has been discontinued |
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| Author：中國銘鉉 企劃部 Release Time：2017-9-4 10:40:26 Number Browse：811 |
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Medical network - on September 4, "medical equipment production and the quality control standard" (hereinafter referred to as YiXie GMP) fully implement entered the countdown, since January 1, 2018, all the first, second, third class medical device manufacturing enterprise shall conform to the YiXie GMP requirements.
This among them, the third type of machinery companies already one step ahead in the landing YiXie GMP, drug safety related fly check action at all levels is a wave, a large number of enterprise was ordered to stop production, rectification, even by investigation.
In order to ensure that the first and second type of armed enterprises can also meet the deadline, on August 31, the CFDA issued a notice to the provincial drug administration on the implementation of the GMP for the first and second class of armed enterprises. The notice was posted on CFDA's website on the afternoon of September 1.
The notice clearly requires that provincial drug supervisors should attach great importance to the formulation of targeted and operable implementation plans to ensure the implementation of the GMP implementation.
Notification:
The first and the second type machinery enterprise shall, according to the requirements of YiXie GMP and relevant appendices to our quality management system to conduct a comprehensive inspection, rectification, since January 1, 2018 still cannot achieve YiXie GMP requirements, shall stop the production, and report to the local municipal food and drug administration.
From January 1, 2018, provincial drug supervisors shall carry out supervision and inspection of the first and second type of armed enterprises in accordance with the requirements of the GMP and related appendices.
The notification requirement shall be no less than 50% of the "double random, one open" sampling rate of the first and second type armed enterprises. In case of complaint reporting or product quality sampling, the enterprise should be checked.
That is to say, most of the first and second type of armed enterprises will be checked by the drug inspectors to verify the implementation of GMP.
During the inspection, found that the machinery enterprises have not established in accordance with the provisions of the quality management system, as well as below-standard YiXie GMP and improvement, production, and report in accordance with the relevant provisions, will be in accordance with the regulations on the supervision and administration of medical devices.
The relevant inspection results shall be made public; Illegal enterprises shall be exposed.
The notice also suggests that CFDA will carry out the flight inspection of the first and second type of armed enterprises in due course.
"Did not notice, don't say" hello ", don't listen to the report, need not accompanied by reception, went straight to the grassroots and into the scene "flight check, often accompanied by different cross pattern, in the high risk of third class medical device production enterprise" appalled ", after the fall to the first, the second category of medical equipment manufacturing enterprises.
Time waits for no one, only four months to go.
The CFDA's "strictest" rule has already been made, and a third class of weapons has been rigorously checked for the GMP's warning, and the "wayward" days of the first and second armed companies will be over.
Is your GMP compliance? Does the quality officer work? Is the production record traceable? Is there an unlicensed site for production? ......
In the remaining four months, self-check, rectification in place, the storm is coming soon, if not the compliance, will be stopped directly!
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