NSF International, an independent global public health and safety organization which develops standards, and tests and certifies products for the pharmaceutical, dietary supplement, food, water, and consumer products industries, has decided to offer secondary reference standards in India, helping meet the growing India pharmaceutical sectors’ need for high quality, economical alternatives to pharmacopoeia standards.
In addition, to meet growing US Food and Drug Administration (FDA) concerns regarding the control of impurities in pharmaceutical dosage forms, NSF is releasing test kits that will include the active pharmaceutical ingredient (API) as well as all pharmacopoeial listed impurities.
As required by US and EU regulations, a secondary reference standard must be demonstrated to be traceable to the primary standard (USP or EP) through laboratory testing. Unlike other secondary standards, NSF Secondary Reference Standards are qualified through a unique process that requires a minimum of three collaborating laboratories and an independent expert technical review board that approves all NSF standards before their use. As this level of characterization is unsurpassed by other secondary standards providers, NSF Secondary Reference Standards are widely accepted by international regulatory authorities and traceable to both US and EU Pharmacopoeia standards (USP and EP). Purchasers also benefit from a 40-50 per cent cost savings over purchasing USP and EP standards.
To help manage the increasing demand of NSF Secondary Reference Standards in India, NSF International has hired two new business development managers – Haresh B Jeswani and Ajay K Goud - based out of Mumbai and Hyderabad.
“NSF Secondary Reference Standards set the bar for the quality and purity of pharmaceutical products while also offering companies in India favourable pricing,” said Lori Bestervelt, NSF chief technical officer and senior vice president over the NSF Health Sciences Division. “Jeswani and Goud both have considerable expertise in pharmaceutical quality and provide NSF customers in India and throughout southeast Asia with unsurpassed service and access to high quality NSF Reference Standards as well as other important training, testing and consulting services through NSF’s global health sciences division.”
In addition to NSF Reference Standards, the NSF International's Health Sciences Division offers training and education, consulting, GMP and GLP testing, certification, R&D, auditing and regulatory guidance for the pharmaceutical, dietary supplement and medical device industries throughout the entire product lifecycle.