Giuseppe Fedegari: «The shortcut to training: working with people who already have the experience»
Today, a 3-day training workshop for experts of the pharmaceutical inspectorate with international participation has been started. The event has been organized by FSI «SID & GP» of Minpromtorg of Russia together with the pharmaceutical equipment designer and vendor FEDEGARI and the international expert in pharmaceutical quality management No Deviation.
Within the Memorandum on cooperation between the Russian state authority empowered to audit and inspect pharmaceutical facilities against GxP requirements and the Italian designer of solutions for clean and sterile processes, Russian pharmaceutical inspectors started the training course under the joint program of FEDEGARI and No Deviation. The training program was dedicated to drug product lifecycle management.
Opening the workshop, the Director of FSI «SID & GP» Mr. Vladislavl Shestakov noted that the issues of sterile manufacture, industrial decontamination and process verification are of great focus during GMP audits. Due to this, discussion-based workshops by suppliers of state-of-the-art pharmaceutical equipment offering solutions for thermal sterilization, the aseptic process, cleaning and complete disinfection of medical devices with GMP inspectors having extensive experience in manufacture are an integral practice of improving pharmaceutical manufacturing processes. The same was emphasized in the welcoming word addressed to representatives of the Russian pharmaceutical inspectorate by the President of the Fedegari Group Mr. Giuseppe Fedegari: «The pharmaceutical world is now entering a new quite complicated, still exciting era: new scientific developments result in emerging of innovative drugs and transition to personalized medicine. Such a transformation is almost a revolution. It means that today drug manufacturers and equipment vendors must switch to closer cooperation.» At the same time, as Mr. Fedegari pointed out, the role of regulatory authorities is gaining significance – in future, they are going to strengthen the influence in terms of promoting safe and high-quality drugs to the market. Consequently, regulatory authorities are becoming the third stakeholder in the process of increasing the efficiency of manufacturing systems in medicine and pharmacy.
«Regulators should not only be aware of critical parameters and processes of pharmaceutical facilities, but also understand whether new technologies and solutions allow for securing safety and quality of the drugs manufactured», assured the representative of the Italian group of companies.
- The volume of Indian drugs in the Russian market was $770 mln in 2018
- Mr. Vladislav Shestakov called for taking a quantum leap in GLP
- Interaction points were discussed by SID & GP with EDQM
- The inspection of the foreign pharmaceutical company registering its drug product in Kazakhstan was carried out by the Russian Inspectorate
- 157 license holders out of 189 manufacturing sites have received a GMP-certificate following the procedure of filing an application