For a third time, the New Guyana Pharmaceutical Corporation Inc. (GPC) has successfully completed an audit by the United States Food and Drug Administration (FDA) that allows it to continue exporting its manufactured products to the country.
Speaking with the Sunday Stabroek, General Manager of New GPC, Ravi Ramcharitar, confirmed that the US-FDA had sent a team to do an audit of the company’s operations in October last year and after it was completed, no issues were found that would disqualify them from exporting to the United States of America.
As a result, the company was once again given the greenlight to continue exporting their manufactured drugs.
“We basically are subjected to the US-FDA scrutiny because we export our products to the USA. There is no start date, once you are exporting you are subjected to an inspection and scrutiny. However, because we manufacture pharmaceuticals that is why they usually come down and do an audit of the plant, and not only the products, but they also want to ensure that the processes are being followed on a continuous basis to guarantee the quality that is required,” Ramcharitar explained.
Even though the New GPC has been exporting their products since January 2000, he said that the US-FDA audits only started in 2012. Since then, there have been two additional audits, including the most recent one.
Before last year’s audit, the last completed audit was conducted in 2014. Prior to 2012, no checks were done and Ramcharitar noted that the increasing number of checks shows that the US-FDA is becoming more strict and stringent with exporters.
“This is our third audit in about six years. They don’t necessarily have to come every two years, that is just how it happens but they can come in four years. When they came in October last year, they spent about three to four days and it’s always an overseas-based auditor and every time a different team comes so there is no chance of familiarity,” he added.
Ramcharitar further explained that the team usually does checks on the entire process, starting with their selection of suppliers to how they test their products that are being imported, in order to ensure quality. The process of receiving products, storage and the use of those products in the manufacturing process, as well as accountability for all materials throughout the processes are also audited and scrutinised.
Outside of the manufacturing process and the products’ use, he also pointed out that they also do tests on other variables such as the water and the stability of the materials, among others. He said that they can do checks and tests on whatever they need to but mostly focus on the manufacturing process and the utilities that impact the process.
“We are pleased to say we did not have any negative feedback and we have been improving all the time. In addition, we have, as a manufacturing quality assurance, a quality management system, quality standards and procedures and various other procedures and protocols that speaks to every aspect of our operation and how we operate and manage and evaluate various processes and systems,” he said.
To ensure that their quality is maintained at an optimum level, Ramcharitar noted that they have a quality management team that is outside of the manufacturing team that monitors the systems and processes.
“As you know there’s a lot of talk about quality and I think that our US-FDA audit is a testament to the attention we pay to quality and manufacturing in Guyana and I think a lot of people have preference for overseas-based products but they can be assured that [New] GPC products that are manufactured right here at home are at a high level of quality. There’s no guarantee to what people import and I just want to encourage Guyanese to buy local,” he added.
