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Learn How To Manage Compliance In The Globalized Pharmaceutical Industry
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In fact, the economy is rapidly globalizing. A product that is developed in one part of the world, could be manufactured in another, and even sold in an entirely different country. While this can be a lucrative venture for a number of companies, depending on the industry, there could be a number of difficulties as well. This is certainly a situation for the pharmaceutical industry today.
A number of American companies have found that outsourcing some of their processes can allow them to operate on lesser budgets.
In the United States, the Food and Drug Administration - FDA plays an important role in approving drugs for commercial use. From regulations that have certain authorizations about how research is conducted to processes such as the CFR Part 11 Audits, which makes sure that research is conducted accurately, there are a number of set of rules & regulations to which companies in the U.S. need to stick on.
With pharmaceuticals becoming more international operations, it brings lots of challenges and difficulties in form of FDA regulations. Facilities in other countries may not be as well ready to meet the standards of the FDA, meaning that international companies could face the risk of having products not approved for commercial use.
This is especially the case with generic drugs. As the patent expire on certain treatments, the door opens up for other companies to start producing the medicine.
Loads of of these nonspecific drugs are the ones that are being outsourced to other parts of the world, like India. As a result of this, companies require to make sure to meet the same compliance standards that are used in the U.S. Failure to do so could lead to fines and mean that the drugs produced at that facility cannot be sold in the U.S. until they are able to meet standards.
This is one of the main reasons why using compliance software in pharmaceutical manufacturing plants is necessary for companies that want to do business in a foreign country.
India to implement regulations
Indian Express reported that the Indian government is setting up its own series of regulations for pharmaceutical manufacturers that are similar to those of the FDA and European equivalents. The government certainly has a stake in making sure that these medications are able to meet the standards of these foreign regulatory groups as they make up a major component of Indian pharmaceutical exports.
"Nearly 30 percent of the generic medicines consumed in the US is manufactured by Indian drug makers. This is not a new phenomena but this has been the same for the last 10 years," said an Indian government official, according to the news source.
Indian Express also noted that the U.S. is the top market for Indian pharmaceutical exports, making up about 26 percent of its total in 2012, with the UK, Germany and Russia following close behind.
The government will inform companies in advance of an inspection, and if the drug control officers identify a violation, the company will have a 45 day window to bring its operations up to standard. This policy comes as the U.S. FDA has issued violations and warning to a number of companies operating in India.
Coming under increased scrutiny
Business World reported that the FDA recently warns a number of companies and has blocked the sale of products in the US.
The news source noted that the FDA has grown stricter in its enforcement of these regulations because of its commitment to making sure that the U.S. consumer and pharmaceutical industry as a whole is well equipped for globalization. As a result of this increased scrutiny, many in the industry foresee that there are more laboratories will face increased scrutiny and the potential of having products blocked by the FDA .
Another issue that has arisen is the use of foreign-sourced materials in these drugs. The FDA is concerned that this could lead to vulnerabilities in the content of these treatments. This is another important challenge that drug companies need to make sure that they address when they implement their compliance solutions.
While globalization is certainly a lucrative endeavor, if not done properly, it can be quite costly. This is why it is so essential that manufacturers and other companies involved in the pharmaceutical supply chain use compliance software to make sure that they meet the standards of the FDA.
Contact Complianz world for Pharmaceuticals Compliance Training
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