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:

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:

  • Quality management
  • Staff
  • Premises, equipment and materials
  • Premises, equipment and materials
  • Premises, equipment and materials
  • Quality control
  • Contract job
  • Reclamation and recall of products

2. Common information on the procedure

GMP-preaudit with ImG

Common information on the procedure

working days

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.

Contact details

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