Medical network - March 17 in recent two days, spread a message in medical circle: GMP, GSP, GCP, GLP certification cancellation is the basic, production, circulation is more likely to the joining together of two card. E medicine manager said the message from the CFDA legal department related people.
The certification once cancelled, a government and to delegate. Is unclear, however, the relevant certification cancelled, whether will advance in the field of medicine.
For medical device companies, now has a abnormal urgent thing, that is to make their own enterprise completely accord with the requirement of YiXie GMP.
YiXie GMP deadline in the future
On September 5, 2014, the state administration of drug safety alerts, medical equipment production quality management specification (YiXie GMP) execution problems shows three time points:
1, since October 1, 2014, every new start medical equipment manufacturing enterprises, the existing machinery enterprises to increase production of class iii medical devices, migration or increase production sites, shall conform to the YiXie GMP requirements.
2, since January 1, 2016, all the third type of machinery enterprises should conform to the YiXie GMP requirements.
3, since January 1, 2018, all machinery enterprise shall conform to the YiXie GMP requirements.
Opened the machinery in new companies and the third type of machinery companies successively experienced YiXie GMP implementation after the big test of the first, the second category of machinery companies will also be welcomed YiXie GMP this year before the end of last year.
This year the key supervision YiXie GMP implementation
It is understood that in the previous 2017 national YiXie supervision work conference, drug safety administration has stressed that the medical device manufacturing supervision and inspection in the field of 2017 key is YiXie GMP implementation, and across the country to promote the implementation of GMP YiXie task abnormal urgent.
Bureau deployed around 2017 take stable cross guidance, demonstration lead three main measure and check the reversed transmission, promote production enterprise implement YiXie GMP; To increase for the first and the second category of production enterprises to implement YiXie GMP stable cross, supervise and guide the enterprise established in accordance with the specification requirements within the time required to produce the quality management system and ensure the effective operation.
Administration will release documents to the first category, the second category of machinery enterprises to implement YiXie GMP give specific guidance, and continue to urge the enterprise to carry out the YiXie GSP specifications.
Inspection, sampling, training... A variety of means to fly together
In place, the shandong province food and drug administration, are also has pioneered the deployment.
Shandong province bureau decided to March 2017 to December, deployed to carry out the medical equipment production and business operation in the whole province in the implementation of "norm" activities.
Note that the activity is not only geared to the needs of production enterprises, and enterprises, the purpose is to ensure that all production before January 1, 2018 companies and products cold chain management enterprise establishes the conform to the requirements of the specification of the quality management system, and continue to urge the third business enterprise carry out YiXie GSP requirements.
The specific arrangement is as follows:
1, stable cross guidance phase (3 months). With production companies, cold chain management products business enterprises and the third class management as the key point, to carry out the relevant laws and regulations and normative stable cross training; Through a baseline survey, symposium, field support, specific guidance to urge enterprises to establish and maintain effective quality management system operation.
2, comprehensive rectification stage (April to may). Organize production enterprises, products cold chain management enterprise and the third class enterprise control of medical equipment production and operation of quality management standards and requirements, to conduct a comprehensive inspection and submit the inspection report, improve the quality management system, improve the quality management support capability.
3, supervision (June - September). Each city bureau organization for the second category of medical device production enterprise and products cold chain management enterprise to implement the quality management standard to carry out supervision and inspection, for the first production enterprises and other third class business enterprise to carry out the double random inspection, and in accordance with the public examination results. ShengJu to each city bureau to supervise and inspect the case timely to carry out the supervision inspection.
4, demonstration leading stage (October - November). Each city bureau respectively select 1-2 home as a typical demonstration enterprises, and take discussion exchange between enterprises or live visit demonstration enterprises, promote the production and operation enterprises within its jurisdiction to implement the quality management standard. ShengJu will organize random part of the production and operation enterprises, and typical demonstration enterprises of various cities recommended for review.
5, summarizes the ascending stage (12 month). ShengJu to summarize in the implementation of "norm" activities, and to the city bureau activities to carry out the situation as a year-end appraisal reference basis.
Arrangement deployment, in shandong province to carry out the administration of "stable cross guidance, demonstration leading three main measure and check the reversed transmission" with requirements. The arrangement of other provinces or with the same.
Bureau of shandong province, however, has not put forward to use the means of flight check. However, from the third class machinery companies GMP implementation, examination to fly verification will be around the administration of drug safety and an important means of supervision.
In 2016, in view of the third type of machinery companies YiXie GMP implementation problems, drug safety administration issued by the three documents, guide around 62 set up the advanced demonstration enterprises. Across the country in accordance with the GMP requirements check 7159 times of production enterprises, shall be ordered to make rectification, 546 times, review 1811 times, investigated 151 illegal enterprises.
For the first and the second category of machinery companies, was to investigate and punish illegal enterprise quantity or more. |
