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
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
Due to the worldwide COVID-19 pandemic, attention continues to be focused upon the use of hand sanitizers as an important part of everyone’s personal hygiene program in an attempt to safeguard health. We all use hand sanitizers at home, at work and even in public places where hand sanitizer dispensers
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
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
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
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,
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
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
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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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
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
Due to the worldwide COVID-19 pandemic, attention continues to be focused upon the use of hand sanitizers as an important part of everyone’s personal hygiene
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),
USP testing has long addressed concerns surrounding heavy metals — so why have they eliminated the Heavy Metals testing as outlined in General Chapter <231>?
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
The Food & Drug Administration (FDA) has a standardized set of principles that ensure the safety and consistency of pharmaceutical and cosmetic products. Being compliant
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
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
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”
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