Position:home>GMP medicine>
Examination of animal drug GMP checks and accept working system
From;    Author:Stand originally
, inspection team staff is comprised
Every inspection team is comprised by 3-4 person, be chosen from library of expert of animal drug GMP hold the post of a group leader to should be an organization capability is strong, professional level is high, the principle can hold to in checking test stop work for the day to make, the comrade of objective justice, the product production management that the member that equipment examination is comprised should be familiar with an examination to check and accept company place to produce and quality supervise a case.
2, examination discipline requirement
Censor forbids to participate in a likelihood to check and accept influential activity to judicial executive examination, include:
1, forbid to accept the valuable that be mixed by the case gift of check business, negotiable securities;
2, forbid to be submitted an expense account by examination enterprise any fee that should pay by the individual;
3, those who forbid to participate in enterprise GMP to run software is paid transfer an activity;
4, forbid to hold two or more posts concurrently in the enterprise or take on advisory;
5, forbid to undertake to be being checked to check and accept an enterprise paid advisory service activity. Every undertook to some enterprise on-the-spot guidance is mixed of advisory service, enter the examination activity of pair of this enterprises no longer.
3, examination note
1, censor should objective justice, listen to business sentiment patiently, avoid subjective and arbitrary;
2, the responsibility of censor is whether assess enterprise accords with GMP standard, is not to should seek advice from division specific teach an enterprise how to be done, the issue that how becomes should be decided independently by the enterprise;
3, examine code and company system, standard to carry out circumstance and latter rationality problem.
4, requirement of examination time limit
1, every examination checks and accept the examination of the group to check and accept an activity not to surpass 4 industries (include 4) ;
2, every enterprise a the form of a drug (or product line, or medicine of a raw material) check time not less than 2 days, every add a the form of a drug, should increase not less than 1 day.
5, flow of spot inspection job
1, first the conference
Join meeting staff: Inspect group of crew, drug of provincial animal drug politics, medical check staff member, just be attended by the examination personnel includes the controller of legal entity, departmental door, enterprise middle-level that concerns with examination limits technology and administrator.
Conference technological process: (1) checks the member that group leader introduction checks composition, read out checks discipline of arrangement of course of limits, examination, program, work; (2) listen to company report, define contact person.

2, spot examination
Check a course: Environment of plant area periphery and plant area environment -- , manufacturing workshop -- support features -- storage -- qualitative check room.
Previous12 Next