pharmaceutical testing
OTC Pharmaceuticals
William J. Neumann

Method Validation vs. Verification vs. Transfer: What’s the Difference?

When testing regulated products such as Pharmaceuticals (Prescription and Over-the-counter), Medical Devices, Dietary Supplements or even Cosmetics, the test methods employed must meet certain performance requirements or the results obtained from using the methods will not be accepted by regulatory agencies such as FDA. The way to determine the reliability

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stability testing
OTC Pharmaceuticals
William J. Neumann

Stability Testing Requirements For OTC & Drug Products in the USA

All over-the-counter (OTC) and prescription (Rx) drug products distributed within the USA are required to display an expiration date that is supported by stability studies that have been conducted in accordance with the current FDA and ICH Guidelines. Each strength of a drug product, and each primary package and closure

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Best Practices
CPT Labs

Why It’s Important to Work with FDA Compliance Consultants

The Food & Drug Administration (FDA) has a standardized set of principles that ensure the safety and consistency of pharmaceutical and cosmetic products. Being compliant with the FDA means that products are safe to use and properly labeled.  FDA compliance isn’t something that should be overlooked or taken lightly. Otherwise,

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OTC Pharmaceuticals
William J. Neumann

GMP Regulation of Sunscreen Products

What is GMP? GMP is an abbreviation for the Good Manufacturing Practice regulations for Drugs/Finished Pharmaceuticals.  It is often referred to as CGMP where “C” denotes “current”. What are the GMP Regulations and Why Do They Exist? The GMP regulations establish a minimum set of requirements governing the manufacturing, processing,

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