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GMP: theory and practice

2 February 2011

On January 29, 2011 in Moscow a GMP master class: “Compliance with the international GMP standards as a condition of the successful business at the contemporary stage” took place. In view of entry into force of a Federal law “On circulation of medicinal drugs”, GMP standards are made into public policy according to which manufacturers of pharmaceutical preparations are to transfer to the international quality standards soon.

The master class was organized by the Institute of Communication Management of the State University - the Higher School of Economics and brought together representatives of pharmaceutical factories, which are implementing GMP standards into the manufactories as well as lecturers of the leading Russian universities which are training specialists for pharmaceutics.

The training was conducted by Elena Sergeeva - certified leading auditor of quality management systems according to ISO 9000 and GMP international standards, candidate of pharmaceutical science (Saint Petersburg), Member of International Society of Pharmaceutical Engineering (ISPE) since 2004. Elena Sergeeva has experience of independent appraisal of quality management systems concerning requirements of international GMP standards within the scopes of objects of biopharmaceutical, chemical, cosmetic industries, public health institutions; she is an author of methods of GMP auditing of manufactures producing APS, GPS, pharmaceutical additives, cosmetic products for Russian and foreign clients concerning GMP standards of WHO, GMP EU, ICH Q7, IPEC, GMP/ ISO 22716.

During the master class, in which the company GEROPHARM was represented by 3 people, the main accents were made on the analysis of the general state of the domestic pharmaceutical industry concerning availability for transfer to the international GMP requirements. Audience was given a detailed account of hierarchy and interaction of the international regulatory and certifying authorities, presented comparative analysis of approaches to the appraisal of quality management system. Elena Sergeeva shared her experience of international inspections of pharmaceutical manufactures and noted that in the process of certification they would pay particular attention to quality control of row materials and additional materials, and therefore to selection and certification of suppliers.

“The subject of training is very topical, - Irina Nikitina, Deputy Director, Head of a Registration Department of GEROPHARM, noticed. – Standard for obligatory transfer of manufacturers of pharmaceutical preparations to the international quality standards by the year 2014 stimulates development for many companies. And although GEROPHARM had started to form it own quality management system according to GMP requirements long before the law was passed, this master class was very timely and useful for us”.

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