Ecuadorian Rainforest LLC (ER) announced the release of a special report created to help manufacturers comply more efficiently with the Food And Drug Administration's Good Manufacturing Practices (GMPs).
The report offers manufacturers and ingredient brokers five tactics to use when working with their suppliers in order to facilitate ingredient testing and procurement. By making this process go more smoothly, manufacturers can save time and money. They can avoid costly re-testing of ingredients and ingredient batch rejection.
"Many of the manufacturers we work with are frustrated with the expenses and production delays that arise when working with suppliers who don't do their homework to help manufacturer meet GMPs," explains ER Vice President Steve Siegel. "Problems like improper ingredient testing and incomplete ingredient documentation have made it increasingly difficult for manufacturers to keep production running smoothly."
As Andrew Shao, former senior vice president of scientific and regulatory affairs for the Council For Responsible Nutrition, pointed out in a 2010 HerbalGramarticle, these issues can be resolved through strategic ingredient supplier qualification as required under the newly enforced FDA GMPs.
Yet this process is confusing.
"The regulations, as written, were fairly broad," assesses Jason Soltis, ER in-house counsel and compliance director. "In a way, that was a great thing because it allowed for greater variety in implementation. It's also a double-edged sword, though. When you don't have lots of guidance from the offshoot, companies are unsure of what to do and there are huge discrepancies in how things are done."
The report, 5 Ways Strategic Ingredient Supplier Qualification Can Save You Time, Money and Headaches, provides manufacturers guidance in working with their suppliers to avoid problems. This report describes tactics that will help manufacturers:
· Avoid retesting and rejecting ingredient batches by knowing what key points to discuss with suppliers at the beginning of contract negotiations.
· Know what to ask for when requesting a certificate of analysis (COA).
· Get critical information and test results more easily by looking for specific qualities in ingredient suppliers.
· Use suppliers' knowledge of seasonal variations and harvest conditions to purchase strategically and reduce testing, thus saving time and money.
· Learn about the common quality control problems of 4 popular botanicals (bilberry, boldo, noni and Irvingia gabonensis) and find out what to look out for in purchasing them.
"A good supplier can provide ingredient buyers better service by doing two things," explains Marlene Hurtado-Siegel, ER founder and president, "One, develop strong relationships all the way down the supply chain—right down to the farmer—in order to ensure quality and good documentation of ingredient production and processing. And two, communicate early on with customers to make sure testing methods and other criteria match up with what our customers need for GMP purposes."
Since many of the challenges in securing ingredients while complying with GMPs revolves around testing of ingredients, the report draws on the insights of ER partner labs, Advanced Laboratories Inc. of Smithfield, North Carolina and Alkemists Labs in Costa Mesa, California.
A supplier of fine natural ingredients from South America and beyond, Ecuadorian Rainforest LLC has been helping natural products manufacturers maintain quality and smooth production since 1997.
To get a copy of this free report or to find out more about Ecuadorian Rainforest's products and services, please visit http://goo.gl/qB2en, call 973-759-2002 or email [email protected]