Subject: GMP
From: "IVANUSA, Marijan" <[email-masked]>
To: Sopo Belkania; [email-masked]
Cc: KLIMIASHVILI, Rusudan <[email-masked]>; POLISHCHUK, Olexandr <[email-masked]>;
Date: Mon, 5 Feb 2018 20:53:54 +0000

Dear Marina, dear Sopo,

As agreed at the meeting last Wednesday, I am forwarding the following information kindly secured by our team in the regional office:

1.       The dates for the training of inspectors at Pharmacon:

Module 1: 18-29 June 2018 at Pharmakon in Denmark

Module 2: 28-30 August2018 (two days audit at pharmaceutical company in Georgia and one day for follow-up – location is not at the pharmaceutical company)

Module 3: 9-11 October 2018 (two days audit at pharmaceutical company in Georgia and one day for follow-up – location is not at the pharmaceutical company)

2.       Qualification criteria and competencies of future inspectors:

According to Georgia accession agreement with EU herewith below refers to the Compilation of Community Procedures on Inspections and Exchange of Information as of 03.10.2014

www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf

Page 56 Guideline on Training and Qualifications of GMP Inspectors:

General aspects

Member States should appoint inspectors to inspect the manufacturing sites according to Directive 2001/83/EC, Directive 2001/82/EC and Directive 2001/20/EC. There should be sufficient resources at all levels to meet, effectively and efficiently, the EU requirements of verifying compliance with GMP of medicinal products.

The inspectors shall be officials of, or appointed by, the competent authorities of the Member States in accordance with national regulations and follow the provisions for the national competent authority.

All inspectors should be competent to carry out their assigned duties and receive appropriate training. When needed, teams of inspectors may be nominated comprising inspectors with appropriate qualifications and experience to collectively fulfil the requirements necessary for conducting the inspection.

The inspectors should be made aware, of and maintain confidentiality whenever they gain access to confidential information as a result of GMP inspections according to applicable national laws, European requirements or international agreements.

There should be sufficient resource to ensure availability of competent inspectors to work according to contracts between EMEA and the competent authority in the case of inspections requested by the CHMP or CVMP.

The training needs of inspectors should regularly be assessed within the requirements of the applicable quality system of the Competent Authority/Inspectorate and appropriate actions taken by the competent authority to maintain and improve inspection skills.

Information on the relevant experience, training and qualifications of the individual inspector must be documented and maintained by the competent authority. These records should be kept up-to-date.

Personal qualities

The inter-personal skills of an inspector are important in helping to achieve the objectives of inspections.

During an inspection the inspector should help in creating an open atmosphere. Inspectors need to remain objective during the inspection and in this context should answer questions or provide clarification but avoid entering into the role of a consultant.

The inspector should have a high level of personal integrity, maturity, be open-minded, understanding of complexity, possess sound judgement, assertiveness, analytical skills and tenacity and have the ability to perceive situations in a realistic way.

The inspector should have demonstrated competence in clearly and fluently expressing concepts and ideas orally and in writing in their officially recognized language.

Qualification

Inspectors should preferably have the same level of qualification as the "Qualified Person" as defined in Art. 48 of Directive 2001/83/EC, in Art. 52 of the Directive 2001/82/EC and therefore be eligible as a Qualified Person.

The inspector should have knowledge of the national legislation as well as systems, both at national and at Community level, for applications for marketing and control of medicinal products.

The extract from the EU directive https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf  I attach herewith.

It is a straight forward selection criteria for the future inspectors.

At least four years of theoretical and practical study in one of the following scientific disciplines is required:

pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.

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 one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.

3.       Immediate technical assistance/mission to Georgia

We propose one week mission which will be divided into two parts.

2 days of interactive presentations on main regulatory issues with a focus on GMP/GDP implementation, import licensing, WHO certification scheme, etc.

This should be a dialogue with NRA (National regulatory Authority) and main actors (manufacturers and distributors).

Max 25 participants – 8 inspectors and 17 distributors/manufacturers.

3 days to work with the NRA (mainly inspectors which by that time will be already selected and focal person for communication appointed) on the development of internal guidelines, QMS, SOPs, etc.

It is really vital that future inspectors will be selected and  their motivational issues resolved by that time.

Development of the GMP/GDP strategy implementation plan will be an outcome of this one week technical assistance.

On the last day – debriefing to the Minister with the explanation of what was done and the presentation of the action plan for GMP/GDP implementation.

The team of experts (their agreement to participate already received)

Oleksii Soloviov, former head of State Administration of Ukraine on Medical Products

Roman Gurzhii, Ukrainian inspector on GMP/GDP and MD inspections (currently)

Mkrtich Shakaryan, Current Head of GMP/GDP inspection in Armenia

Estimated dates of visit 12 – 16 or 19 – 23 March 2018.

Terms of Reference and costing will be shared with you as soon as possible (incl. the option to fund this activity from the BCA workplan).

The goal is to secure participation of Georgia in WHO Certification scheme and application for PIC/S membership by the end of October 2018.

This is only possible with strong political commitment and hard work.

The above proposal is very operational.

We are still working on possible funding of the work, but at this stage I cannot provide any answer. Yu will be informed as soon as there is any news.

At this stage we are not able to secure any inspectors for immediate GMP inspection and we strongly advice to postpone inspection for future, when it will be a natural stage in the process of establishing the inspectorate.

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