Published on : Feb 16, 2015
With an aim of ensuring better adherence to global quality standards in pharma industry, the World Health Organization (WHO) issued fresh set guidelines on Good Pharmacopoeial Practices and is hoping for the industry to comment on its proposed guidelines before 10th March, 2015. Pharma industry on whole has appreciated the drive to enforce stringent quality regulations by WHO, since it will enable them to foster better quality standards.
Pharmacopoeias at present are confined to their respective regional and national regulatory compliances. It is not possible for the companies to break out of the stringent regional regulations and adhere to retrospective standardization. Hence, the hope that prospective harmony could be easier to achieve despite of being abreast of certain challenges that needs to be addressed at the initial stage. With regards to ongoing trends in medical and pharmaceutical industry, WHO mentioned in its drafted recommendations that process of maintenance over time in case of Pharmacopoeial standards must be guided by long term perspectives.
In order to ensure unhindered development in science and medical practices, the pharmacopoeias need to revise the presence of SFFC (spurious/falsified/falsely labeled/counterfeit) products at regular intervals. The World Health Organization further stated in its draft that harmonization and collaboration among Pharmacopoeial committees and associations coupled with adequate interaction within industry can foster enhanced support to face ongoing challenges, and constraints of resources in the market.
The primary focus of World Health Organization’s Good Pharmacopoeial Practices is aimed to lay down a list of stringent policies and pharmaceutical approaches that will help the industry establish uniform standards of production. These regulatory norms will also help the authorities to keep an eye on the quality of pharmaceutical ingredients, the finished drugs, and other products.