Chinese
Position:home>GMP medicine>
Animal drug produces quality management standard
From;    Author:Stand originally
chapter general principles
The first basis " animal drug regulation " regulation, establish this standard.
This the 2nd standard is animal drug production and the basic standard that quality administers, the crucial working procedure that finished product quality affects in production of drug of the whole process that applies to production of animal drug preparation, raw material.
Orgnaization of the 2nd chapter with personnel
Drug of the 3rd animal produces an enterprise to should build production and quality administration, of all kinds orgnaization and personnel duty should be made clear, provide a certain quantity of has professional knowledge and manufacturing experience administrator that suits with animal drug production and technical personnel.
The controller of the controller that production of drug of animal of officer of company of production of drug of the 4th animal manages and quality management, should have pharmacy or record of formal schooling of above of relevant and professional three-year institution of higher learning, have experience of animal drug production and quality management work.
The controller of the controller of management department of production of drug of the 5th animal and quality department should have record of formal schooling of vet, pharmacy and above of relevant and professional three-year institution of higher learning, production of drug having animal and the practice experience that quality manages, capable that to animal drug production and quality manage medium real problem to make correct judgement and processing.
Animal drug produces management department controller and quality department controller to all answer to be held the position of by full-time personnel, must not hold part-time each other.
The 6th personnel that is engaged in animal drug producing operation and quality inspection directly should have rate of literacy of high school above, have fundamental theory knowledge and real operation technical ability. The personnel that is engaged in producing auxiliary sex to work should have rate of literacy of above of junior high school.
Drug of the 7th animal produces an enterprise to answer plan of formulate Training Within Industry, the of all kinds personnel that produces to be engaged in animal drug by this normative requirement undertakes grooming, classics assessment is eligible and rear but mount guard.
Content active, high to be engaged in Gao Sheng toxicity, strong contamination, Gao Zhimin sex and the animal drug production that sicken is concerned or have special demand in all with person cultivate operate personnel and quality inspection personnel, answer to groom via the technology of corresponding major.
Personnel of the 8th quality inspection should via provincial animal drug censorial place grooms, via card mount guard is being held after assessment is eligible. The appointment of quality inspection controller and change should sign up for provincial animal drug censorial place puts on record.
Previous12 Next