GMP compliance and enforcement is good for the industry, but it is also good for business for suppliers that focus on quality, says George Pontiakos, president and CEO of BI Nutraceuticals.
Speaking with NutraIngredients-USA recently, Pontiakos said that his company’s continuing investment in specialized equipment, employees and quality was helping to increase BI’s market share.
“Very few of our competitors have the capital strength to invest like we are,” he said.
A number of leading industry voices, including the United Natural Products Alliance (UNPA) and the Council for Responsible Nutrition (CRN) , have been reinforcing the importance of complying with current good manufacturing practices (cGMPs), as the Food and Drug Administration increases its enforcement.
Only seven GMP inspections occurred in 2008, which increased to 34 in 2009, 84 in 2010. As of September 13 of 2011, there had been 145 inspections, according to FDA data.
The increase in inspections has been followed by a significant uptick in the number of warning letters for GMP violations: In 2010, FDA issued 8 letters regarding GMP violations. In 2011, that number quadrupled, with 34 companies being cited for a wide range of violations – from failure to establish product specifications to failure to maintain adequate records, according to Ivan Wasserman and La Toya Sutton from Manatt Phelps & Phillips in Washington, DC .
The increase in enforcement was welcomed by Pontiakos as a better use of his tax dollar by FDA than other initiatives, like NDIs.
However, BI’s chief dismissed comments by some industry sources that there are insufficient QA experts available. “If you’re a business owner you have to invest. You can find someone who is lab qualified.
“It’s unacceptable to be intimidated by cGMPs,” he said. “There is no excuse for buying bad product.
“A lot of big companies cannot afford to take a risk with this; they have to buy good product.”
Pontiakos said that 2012 has been a good year so far for the Long Beach, CA headquartered company. The company recently appointed a new marketing manager and lab manager, and increased its lab capacity by 20%, he said.
BI Nutraceuticals also announced a partnership with Canadian-based Quadra Ingredients to further expand its business globally. Quadra offers 40 strategic stocking locations and dedicated ingredient storage facilities, and guarantees BI’s high quality ingredients remain pure and untouched.