India Day 4: Auditing Manufacturer of Standardized Herbal Extracts

Note: Lynda Hammons, VP of Global Quality and Regulatory and Ellen O’Neal, Purchasing Manager, are performing an audit on our suppliers in India through April. They are taking pictures and writing updates from India, and we’ll be sharing some of their experiences on the blog and on social media. Below is part 4, in their words, where they are auditing a leading researcher and manufacture of standardized herbal extracts:

Ellen observes metal detection for botanical extract

 

A leading herbal research-driven company in India was the fourth audit for Lynda and Ellen. This supplier’s core competence lies in manufacturing standardized herbal extracts with a state of the art research center. This center has the expertise to discover and develop innovative & high quality botanical extracts with scientific and clinical validation.

The production facilities are GMP, ISO 9001:2000 and ISO 22000:2005 certified. The in-house R&D center is a government approved laboratory for testing of traditional medicines. The research team has secured 8 patents and has over 100 publications in national and international peer reviewed journals. The PhD scientists have contributed several analytical monographs on Indian Medicinal plants to the Indian Pharmacopoeia, Ayurvedic Pharmacopoeia of India and the United States Pharmacopoeia.

Lynda inspects equipment for blending

 

The Quality Control labs and Research and Development labs of this supplier were some of the best that we have seen at any of our suppliers- located in or outside of India. The facility also contains an extensive library of authenticated voucher samples of Indian botanicals. This allows for thorough and extensive identity testing of each lot of botanicals prior to QA approving the lot for extraction.

The supplier commented that they have been visited by a few customers other than NSP but NSP has definitely conducted the most extensive audit including every aspect of good manufacturing practices and testing.

Part of supplier’s extensive library of authenticated voucher botanical specimens

 

One of the botanical extracts purchased from this fourth supplier is licorice root extract, Glychrrhiza glabra. Licorice grows wild in some parts of Asia including India. A perennial that grows 3 – 7 feet high, licorice has an extensive branching root system. NSP’s licorice extract is made from the roots and underground stems of the plant. NSP’s licorice root is DGL or deglycyrrhizinated licorice which has the ingredient of glycyrrhiza removed. Deglycyrrhizinated licorice doesn’t seem to have the same side effects . Numerous studies have shown licorice extract to be effective for the conditions of peptic ulcers, canker sores, upper respiratory infections (cold, cough) and reflux (GERD).

Two key NSP products containing licorice root extract are Mineral–Chi Tonic , stock 1818 and Gastro Health, stock 917. Go here to see more products with Licorice Root.

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