There are multiple challenges to meeting GMP in Russia including bureaucracy and past pharmaceutical practices.

The state of GMP compliance in Russia is not yet up to Western standards. Currently only 50 of Russia’s 528 drug factories meet international GMP standards. Only 1 of the top 20 producers of drugs sold in Russia is not foreign owned zombie tsunami cheats and only one out of every five drugs purchased in Russia is produced domestically. The most concerning statistic is that 90% of pharmaceutical materials sold in Russia are from unknown origins.

The history of GMP compliance in Russia is very different than in the West. Until 1991 the Russian economic systems and principles were completely communistic. All property belonged to the state. All plants received plans and orders for manufacturing of products from the state. Supply of all materials was centralized and controlled by the state. Thus the plant managers were not concerned about meeting standards as much as meeting their duty to fulfill state plans. Under this system, the state consumed 100% of manufacturing capacities and the state created the mandatory standards.

So the state had several roles in pharmaceutical manufacturing:

?it was the only customer,
?it was the only supplier,
?it was owner of plants,
?and it was the authority that created standards and controlled compliance to them.

All this was controlled by a huge bureaucratic system with many institutions that were not concerned about meeting production and quality standards as in the rest of the world. The people who set the standards did so only on basis of their own understanding of how best to serve the interests of the bureaucracy. This changed dramatically in the early 90s when the USSR started to break up. In 1991 and 1998 two nationally oriented standards were approved in Russia. share this site In fact they were compilations of GMP EC text with some withdrawals and changes. They added some new unnecessary requirements that were even more rigid then in GMP EC Guide. It wasn’t until 2004 that the EU GMP Guideline was approved as Russian national standard GOST R 52249-2004 鐜€anufacturing and quality control of medicinal products? This was a direct translation of EU GMP with all 18 Annexes without any changes.

Implementing of GMP EC Rules in Russia should solve several issues:

?Elimination of trade barriers,
?Setting in Russia the same standards as in Europe and giving a normative basis for export of products,
?Upgrading the national pharmaceutical industry,
?Setting barriers to import of poor quality drugs from some countries.

Even with the adoption of new GMP guidelines, new problems have emerged. National standards are not mandatory documents according to kill shot bravo cheats online Russian Law. The Technical Regulations that have been in force since 2004 are only recommendation. One of the most serious problems in Russia is the continued counterfeiting of medicines, mostly antibiotics, which are being sold also through private pharmacies. Sales of false medicines remain high. Although, it is said that there are less counterfeit preparations on the market, their value in 2005 was estimated at $300M.

Pharma 2020 is the Russian government’s intended fix. Pharma 2020 is an initiative headed by the Ministry of Industry and Trade that aims to develop the research, development and manufacturing of drugs by Russia’s domestic pharmaceutical industry. The plan will elevate the market share of domestically-produced generic and original medicines, stimulating local economies. The goal is to raise the share of domestically produced medicines to 50 percent over the next decade, from the current 23 percent. Among the means: modernizing factory equipment and removing administrative barriers to drug registration.

The government plans almost $6 billion in industry-wide investment over this period in training and infrastructure development, GMP practice development and R&D. It wants to take advantage of the market that is growing 10 percent to 12 percent annually on average–especially when it see stats reflecting that, as of 2007, only one out of every five drugs purchased in Russia was produced domestically. And only one of the top 20 producers of drugs sold domestically was a Russian firm. We sincerely hope these aspirations become reality so we can see Russia’s pharmaceutical industry become fully compliant with international standards for GMP.

One approach to standardizing GMP compliance in Russia is to use a manufacturing execution system like InstantGMP where the compliance requirements are hard coded into the software. This is an internet based system with electronic batch record system. It was designed with a pharmaceutical manufacturing quality structure which established the fundamental requirements for this database application. All of the manufacturing SOPs are provided with the system so getting a quality system in place is quick and easy. Since the SOP requirements are built into the application, training and compliance takes place with minimal effort and expense.

Rick Soltero, President of InstantGMP MES, an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of MES, an electronic manufacturing execution system that is web based and Part 11 compliant. He also developed EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.