28 Aug 2012, BioSpectrum Bureau , BioSpectrum
Bangalore: NSF International, an independent global public health and safety organization which develops standards, tests and certifies products for the pharmaceutical, dietary supplement, food, water, and consumer products industries, is the first to offer secondary reference standards in India. This will help the Indian pharma sector to meet its need for high quality, economical alternatives to pharmacopoeia standards.
In addition, to meet the growing US 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 pharmacopeial listed impurities.
As required by the 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 the US and EU Pharmacopoeia standards (USP and EP). Purchasers also benefit from a 40-50 percent 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, Mr Haresh B Jeswani based out of Mumbai and Mr Ajay K Goud based out of Hyderabad.