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
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
Regulatory Status of Cosmetic and Personal Care Products in the US Cosmetic and personal care products sold in the US are regulated by the FDA under the Federal Food, Drug and Cosmetic (FD&C) Act of 1938. In spite of the fact that cosmetics have an excellent safety record, key statutory
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
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
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
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
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
Recent testing of numerous sunscreen products in US distribution has revealed significant levels of benzene in many of the products (mostly ‘aerosol’ products), with some even exceeding the current FDA limit of 2 parts per million (ppm). These findings (which were confirmed by one major US manufacturer’s internal testing of
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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
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
Regulatory Status of Cosmetic and Personal Care Products in the US Cosmetic and personal care products sold in the US are regulated by the FDA
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
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
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
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
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
Recent testing of numerous sunscreen products in US distribution has revealed significant levels of benzene in many of the products (mostly ‘aerosol’ products), with some
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