OTC Pharmaceuticals
William J. Neumann

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

Understanding method validation vs. verification is vital when trying to launch your next regulated product. 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

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OTC Pharmaceuticals
William J. Neumann

USP Eliminates Heavy Metals Test: FAQs Answered

USP testing has long addressed concerns surrounding heavy metals — so why have they eliminated the Heavy Metals testing as outlined in General Chapter <231>? When it comes to pharmaceutical development and manufacturing, USP testing standards ensure quality, purity and consistency. This non-government organization champions public health by safeguarding therapeutic

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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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Specialty Chemicals
CPT Labs

Free of Phthalates Testing Overview

What are phthalates and what are they used for? Phthalates are a family of chemical compounds that are used in many industrial applications but primarily as an additive in nearly all types of plastic and vinyl to improve their durability, transparency and flexibility. Due to the myriad uses of plastics

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OTC Pharmaceuticals
CPT Labs

Free of Allergens Testing Overview

With the increasing prevalence of allergic reactions reportedly caused by foods and cosmetic products over the past decade, it is now common for consumers to scrutinize and compare product labeling at the time of purchase, checking for the presence of any ingredient(s) that could cause an allergic reaction in themselves

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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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