მოგესალმებით,

გთხოვთ იხილოთ თანდართული წერილი და მომწეროთ თქვენი მოსაზრება ხვალ, 18 იანვარს 15:00 საათამდე.

Dear Sopo,

Below is the proposal for the training for the inspectors for the GMP at Pharmakon, Denmark, as discussed during the mission on GMP in December 2017.

We need to have the approval soonest possible as time slots may be used differently by Pharmakon.

The communication focal person from the MoH have to be designated.

This course was developed by WHO EURO and Pharmakon in 2006 and is constantly evaluated/updated.

It was delivered for the inspectors for several countries and “produces” competent inspectors at the end.

The course consists of 3 modules.

Module 1

Theoretical 2 weeks course at Pharmakon.

Estimated course price is 60k USD excluding transportation costs.

Arrival of participants on 17 June and departure on 30 June.

WHO EURO will facilitate the module and all its activities.

Optimal group composition is 20 trainees – as suggested 8 potential inspectors and 12 industry representatives (who should be self-financed by the industry).

At the end of the Module 1 the examination will be carried out to evaluate how trainees gained the knowledge.

Module 2

Practical module in Georgia – 2 day mock-inspection of the pharmaceutical facility.

Inspectors – Pharmakon trainers.

Trainees (8 NRA staff only) – supervising the inspection.

On the day 3 of this module – full day work with trainees on linking observations made during the inspection to EU GMP guidelines and categorization of the observations.

At the end of the course there will be a recommendation by trainers whom to select for the Module 3.

Estimated cost is 60k USD without local transportation and admin. Support.

Module 3

2 day mock-inspection of the pharmaceutical manufacturer in Georgia conducted by 4 trainees selected in Module 2.

Trainers will supervise mock-inspection conduct and make their observations on trainees performance.

Day 3 of Module 3 will be dedicated to the preparation of the inspection report and personal face2face appraisal to trainees.

Estimated cost is 60k USD without local transportation and admin. support

More detailed costing of the course will be made by Pharmakon upon acceptance of training by the ministry.

At the end of the course all trainees will receive certificates with clear explanation of what they have learned.

This mean that by the end of October 2018 Georgia may have fully functional inspectorate and join WHO Certification scheme and apply for PIC/S membership.

Please, be informed that WHO has no resources for the course.

Best regards,