Audit for compliance with GxP
1. Description of the service
The expert team of IMGP, a member of the IMG group of companies, conducts voluntary audits of pharmaceutical companies and their counterparties for compliance with the requirements of Gx practices:
Good Manufacturing Practice
Good Distribution Practice
Good Laboratory Practice
Good Storage Practices
Since September 1, 2010, all pharmaceutical manufactures are required to pass certification in accordance with the law "On the circulation of medicines", which implies the transition of all productions to the recognized world quality standards of GMP.
In providing voluntary audits of manufacturers of medicinal products for medical use, the following areas are considered for compliance with the requirements of the Rules of Good Manufacturing Practice:
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2. Common information on the procedure
GMP-preaudit with ImG
Common information on the procedure
35
working days
01
Approval and signing of the contract with the client
02
Advance payment
03
Receipt of documents (Site Master File)
04
Preparation of the GMP audit plan
Coordination of the audit timing
05
Expert's departure to the object
06
GMP-audit
07
Report of GMP-audit
In the course of voluntary audit by certified experts (Heathside / CII Group certificate), recommendations are made for correcting the deficiencies and violations, the degree of their criticality in accordance with the requirements of the "Rules of Good Manufacturing Practice."
As result of the audit, an audit report is issued, the form, content and procedure for submission of which are determined by the established rules (standards) of audit activity and confidential written report intended for use by the client.
3. The result of the audit
Thus, by attracting the specialists of our company, the Customer receives an objective, real picture of the state of production site, on the one hand - from the point of view of GMP, as close as possible to how state inspectors see it, and on the other hand - the technical / technological assessment of production site for purpose of identifying various inconsistencies and "bottlenecks".
Based on the results of the audit, full and detailed program for the reorganization of production in accordance with modern requirements, preparation of the enterprise documentation for the purposes of state GMP certification is proposed.
