Training of pharmaceutical inspectors from the Russian Federation – World Health Organization (press release)

On 10 – 20 June 2014 a group of Russian experts passed the first training module for pharmaceutical inspectors at Pharmakon – Danish College of Pharmacy Practice. Pharmakon is the World Health Organization Collaborating Centre for Drug Policy and Pharmacy Practice Development, which provides training for pharmaceutical inspectors in the European Region. The Russian experts that attended the trainings included staff of Department of the development of pharmaceutical and medical industry of the Ministry of industry and trade of Russian Federation and employees of the state budgetary enterprise “State Institute of Medicines and Good Practices” of the Ministry of Industry and Trade of the Russian Federation (SBE “SIM&GP”), along with representatives of Russian pharmaceutical manufacturers.

According to the current European Commission guidelines on Good Manufacturing Practice (GMP EC), SBE “SIM&GP” executed the next step of the pharmaceutical inspectors’ development programme through this training.

The active support provided by the WHO Regional Office for Europe (in Copenhagen, Denmark) made the execution of this course possible.

In order to ensure the effectiveness of the learning process, trainers at Pharmakon are using a methodology with the optimal combination of theoretical and presentation materials, role play, individual and group tasks for the trainees and hands-on exercises.

Also, it is an established practice that each training module is followed by critical individual appraisal for each trainee.

Trainers at Pharmakon have extensive practical experience of work with pharmaceutical inspectors from European regulatory authorities. Additionally, some Pharmakon staff recently worked at the Danish pharmaceutical inspectorate.

Evidently the mentioned course is essential, since the key principle in pharmaceutical inspectors’ training is peer to peer knowledge sharing – from inspector to inspector. The detailed analysis of real life situations in the preparation and execution of the inspections of pharmaceutical manufacturers, the expertise in the classification of observations, the ability of keeping the inspection direction and the adherence to the ethical and professional principles facilitated the learning process.

Second and third modules of training will be conducted in the form of real life audits of the compliance of pharmaceutical manufacturers with the EU GMP. The upcoming trainings will be made possible due to the full support of the WHO Regional Office for Europe and the participation of the Pharmakon trainers. The audits will be conducted according to the rules established at pharmaceutical inspectorates within the EU, however these audits will not have any regulatory impacts. Nonetheless, the audit reports will reflect the current status of the quality systems of the manufacturing facilities and may be used by the facilities in their future work.

Previously, a training using the same methodology was conducted for pharmaceutical inspectors from Ukraine, Belarus, Kazakhstan, the Republic of Moldova, Armenia, Georgia and Azerbaijan.

According to the WHO, the use of the unified approach in training will better support close collaborations between inspectors, alongside the harmonization of the medicines regulatory standards and approaches for the inspection of pharmaceutical manufacturers in the Region.