A scientist examining a sample for drug product contaminants
Businesses
CPT Labs

Drug Product Contaminants: Part Three

There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen products, which resulted in high-profile product recalls in 2021.  One might argue that chemical contaminants have always been present in

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Businesses
CPT Labs

Drug Product Contaminants: Part Two

There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen products, which resulted in high-profile product recalls in 2021.  One might argue that chemical contaminants have always been present in

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A scientist looking at a sample for drug product testing
Businesses
CPT Labs

Drug Product Contaminants: Part One

Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant Types of Contaminants that are Found in Drug Products Classification of Drug Product Chemical Contaminants and their Sources API Impurities Extractables And Leachables Supply Chain

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Pharmacist showing customer an OTC Drug
Businesses
William J. Neumann

10 Common Pitfalls When Launching OTC Drug Products in the US

Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.” With only a few exceptions, OTC Drugs may be launched in

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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

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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Our facilities will be closed on Monday, May 30th in observance of Memorial Day.

Due to the forecast calling for snow and out of an abundance of caution we will be having a delayed opening tomorrow. Our facilities will now be opening at 10 AM on January 7th, 2022.