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GMP Preparation

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By: Sean Moloughney

Editor, Nutraceuticals World

Global Lifescience Solutions (GLS) has introduced expanded validation and Good Manufacturing Practices (GMP) services to the dietary supplement and pharmaceutical industries. As a contract research and consulting firm, GLS will provide GMP consulting services to help manufacturers comply with the forthcoming GMPs, which are anticipated to be finalized in 2007. These guidelines will require dietary supplement and pharmaceutical manufacturers to implement additional testing, monitoring and quality systems to their current manufacturing practices. GLS’s broad range of services include: stability storage and testing services in support of expiration dating; test-only services for dietary supplements (e.g. heavy metals analysis, pesticide screening, microbial testing); method development and validation; GMP consulting; safety assessments; New Dietary Ingredient (NDI) notifications; clinical trials; bioequivalency studies; GRAS (generally recognized as safe) affirmations; and third-party testing for compliance with California Proposition 65.

For further information: 734-827-3803.

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