Executive summary
This report relates to a technical audit of the Medsintez Plant Ltd factory, Novouralsk. The audit was carried out between 20 June and 23 June 2005 by Dr Kathleen McCormick of Heathside Information Services Ltd. The facility was audited against the European Union (EU) requirements for Good Manufacturing Practice (GMP) in the production of Pharmaceutical products.
Medsintez Plant Ltd has an excellent quality system, which is being operated effectively. During the audit, no critical or major deficiencies were observed; just two minor deficiencies were identified.
Five points were identified at which the requirements of the Russian regulations differ from those of the EU. In some cases, requirements are higher than those of the EU; the company is complying with these requirements. In other cases, the Russian requirements are lower than those of EU. Currently, Medsintez is working to these lower limits. However, if required, they could easily change to meet the EU standards.
The suggestions have been made regarding possible improvements to the system in order to make operations or checking easier.
It may be concluded that Medsintez Plant Ltd is operating a system that is in compliance with the requirements of EU standards of GMP.
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Kathleen E McCormick (Dr)
June 2005
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