The Ministry of industry and trade of the Russian Federation
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Try on the role of the GMP-inspector

On September 23-25, in terms of the IV All-Russia GMP Conference exhibition, the State Institute of Drugs and Good Practices (SID&GP) will provide an opportunity for the Conference particpants to conduct a virtual inspection on the manufacturing unit.

The hardware-software complex “Virtual manufacturing” is designed and developed by SID&GP in the form of a multiuser application, built on the Unreal Engine solution. The complex was created to improve the inspectors’ skills in an active form. The training virtual inspection of the medicins manufacturing units is carried out in two modes:

  • in the virtual reality mode (for learners), which allows hands-on interaction with the objects of the training system, converting the possibilities of back-coupling
  • in the mode of a standard application (for instructors), allowing the instructors to configure and create separate training sessions with the possibility of including the nonconformities with GMP requirements. The learner’s task is to carry out virtual inspections and record the revealed nonconformities in the system.

On the days of the IV All-Russia GMP Conference with international participation, everyone interested will be able to try on the role of the GMP-inspector, conducting an audit of the virtual plant – the manafacturing stage of granulation – against  the GMP standards compliance. As noted by the representatives of the SID&GP inspectorate, who will act as instructors during the virtual inspection, the virtual plant area is an individually recreated manufacturing company: the “demonstration module” of granulation stage, which integrates the necessary types of pharmaceutical equipment: “This product can be used not only for inspectors training, but also will be a good mechanism for self-inspection at any pharmaceutical company”.

What will the trainee be doing?

  1. After exiting the personal gateway to the main hall of the production shop, you will be following the accompanying Character to the granulation hall, where you will explore the production zone, evaluate the marking, instruments’ indicators and preparation of the premises for conformity with the protocol on drugs.
  2. The character loads sequentially 4 components into the granulator. At this stage, the User is evaluating the correctness of the sequential loading, matching it with the protocol, which is lying on the table, and, also observing whether in the course of his action the character is making notes in the protocol. In case of identifying the deficiencies, the user is noting them in his virtual tablet.
  3. The character is launching the work of a humid granulator, by tentatively selecting the mode. At this stage, the User can make a liaison with the character, by launching the dialogue, during which he can find out the type of strainer that is set at the granulator, and also to have a look what work mode has been chosen in the granulator. He can compare the answers with what is mentioned in the protocol, and also note whether the character is making the notes in the protocol in the course of action, and indicate the identified deficiencies in his own virtual tablet.
  4. The character launches the reset of a humid granulate to the granulate-dryer, and then chooses the work mode in the granulate-dryer and launches it. At this stage, the User can check the conformity of the granulator’s work mode, mentioned in the protocol.
  5. The character is making the selection of samples and checking it for residual humidity, marking in the appropriate manner bins, putting them into the granulates from the granulator, conducting the weighing of the granulate, loading the bins on the trolley and transporting them out of the premises. At this stage the User can check the deficiencies in relation to the weight of the product on exit, and point out whether the character was making the notes in the protocol in the process.
  6. The User is coming out of the granulation premises, the script ends with the display of results of his training session.

ATTENTION! In order to try on the role of the inspector and have a chance to take part in the promising events from the GMP Conference business program, please fill in the preliminary application or send a letter to gosgmpexpert@gmail.com including your full name, job title, organisation’s name and contact information, as well as your preferred participation time in the “Virtual manafcaturing”inspection. The appllications are acceptable no later than September 19.

Dates and venue of the event: September 23-25, 2019, Svetlogorsk city (Kaliningrad region), «Yantar-hall» (Lenin str., 11).

You can register for the Conference until September 13 on the website of the event.

The organizers of the IV All-Russia GMP-Conference are the Ministry of Industry and Trade of the Russian Federation together with the State Institute of Drugs and Good Practices (SID & GP).