Subject: GMP
From: "IVANUSA, Marijan" <[email-masked]>
To: [email-masked]
Cc: Sopo Belkania;
Date: Thu, 15 Feb 2018 08:34:28 +0000

Dear Marina,

It was great meeting you yesterday.

Based on the short discussion we have had regarding the GMP, I have received the following feed-back from the regional office:

As per our understanding the Faculty of pharmacy curricula is for 4 years for bachelors, and some students may go for master course of 2 years = six years in total.

This means that:

The inspector shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.

The duration of practical experience may be reduced… by a year and a half where the course lasts for at least six years (which means half a year of experience).

This mean that in the Post Description for the selection of the candidates Master’s degree could be essential.

Moreover, future inspector shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. (Article 49. 2. of the same Directive)

It means that we have to search not only among pharmacists. For inspections it might be more efficient if there are different experts in the team.

However in this case practical knowledge of manufacturing process and/or quality control and analytical test methods should be present.

At the current stage the ministry needs to select maximum of 8 persons and start development of the plan and preparation for training.

Perhaps the most realistic way is to look first to the existing inspection department staff and make a search there.

Secondly, you may wish to ask for the advice the association of pharmaceutical manufacturers/distributors. Ms Ekaterine Koplatadze from GM Pharmaceuticals is teaching master course students at their facility being associate lecturer of the University.

Ideally all candidates need to be fluent in English language.

As per my understanding, working/practical experience is desirable.

Hopefully this clarifies a bit.

Best regards,

Marijan Ivanusa

WHO Representative

Head of WHO Country Office Georgia

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

Mobile 1: +995 599 305 207

Mobile 2/EU/private: +386 40 528 639

Email: [email-masked]

Skype: who-ivanusam

GPN: 74211

Web: www.euro.who.int