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Blog: Regulatory Requirements for Early Phase Drug Product Development
Supporting a compound from discovery to clinical phases and potentially commercial phases requires an immense amount of time, energy, and money....
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Jeremy Kraft : Oct 24, 2023 4:40:12 PM
by Jeremy Kraft, Sr. Manager, Metrology
Recently, the question of what differentiates A2LA, ANAB, and NVLAP has arisen. While researching these 'big three' metrology accreditation bodies, we identified various distinctions and parallels. A2LA, or the American Association for Laboratory Accreditation, is a not-for-profit and internationally recognized accreditation body. It is among the largest in the world, with a vision of 'Accreditation accepted everywhere.' ANAB, or the ANSI National Accreditation Board, is a not-for-profit organization and the largest accreditation body in the United States. ANAB is a subsidiary of ANSI and resulted from a merger between the American Society for Quality (ASQ) and the American National Standards Institute (ANSI). NVLAP, or the National Voluntary Laboratory Accreditation Program, is an agency run by the National Institute of Standards and Technology (NIST). Serving primarily North America, this agency is a part of the United States Federal Government and prides itself on setting the standard for accreditation.
While all three are internationally recognized by the International Laboratory Accreditation Cooperation (ILAC), there are some key differences. Let’s dive deeper into the distinct features of each:
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Supporting a compound from discovery to clinical phases and potentially commercial phases requires an immense amount of time, energy, and money....
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The FDA has issued Guidance for Industry, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol...
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The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many challenges. There can be an impact on productivity if your...