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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Lab technician working in a lab that requires environmental monitoring
Businesses
CPT Labs

Environmental Monitoring Programs to Reduce Contamination

The term Environmental Monitoring generally refers to the processes and activities that are conducted for the purpose of characterizing and monitoring the quality of a defined environment, with the eventual goal of controlling the quality of that environment. Environmental conditions that are often monitored include but are not limited to

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Businesses
CPT Labs

A Beginner’s Guide to Raw Material Testing

What is a Raw Material? A raw material is a basic material that is used to make a product. The formulation of each product, whether it be a drug, cosmetic/personal care product or dietary supplement is a unique combination of raw materials. Active ingredients, inactive ingredients, preservatives and processing aids

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Female scientist performing in vitro toxicological testing in a lab
Businesses
Steve Nitka, V.P. In-Vitro Technology

Why You Need to Use CPT For In-Vitro Toxicological Testing Services

What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch of the science that investigates those effects using laboratory animals upon which testing is conducted. In contrast, in vitro toxicology is the branch of the

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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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News
CPT Labs

BioSafety & Security Policy Information – March 2022 Update

Biosafety & Security Policy – Updated March 25, 2022 The health of our panelists and staff is our primary concern. CPT℠ has updated our Biosafety and Security policy as of March 21, 2022, based upon Governor Murphy’s lifting of certain restrictions, and ending the Public Health Emergency in NJ. Our

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Businesses
Sonny Mulchandani

Common Pitfalls When Launching Cosmetic Products in the US

Regulatory Status of Cosmetics and Important Legal Concepts The Federal Food Drug and Cosmetic (FD&C) Act defines “cosmetic” products by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the

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FDA Withdrawing Hand Sanitizer Temporary Guidances

In order to assure the continuing availability of hand sanitizers throughout the COVID-19 pandemic, FDA  issued a number of Temporary Guidance Documents aimed at increasing production of hand sanitizers by relaxing some of the basic requirements for OTC Drug products distributed within the USA.  The major elements of FDA’s temporary policy for

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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.