In January, the FDA released the second revision of the Draft Guidance, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” The Agency initially submitted the Draft Guidance in 2014 and followed up with Revision One in December 2018. Currently, GMPs for drug
High Quality Testing Of Drug Substances & Drug Products Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity. A drug “substance,” often referred to as an Active Pharmaceutical Ingredient (API), is defined as the
An antimicrobial or preservative is defined as a chemical agent that will kill or inhibit the growth of microorganisms. Common antimicrobials utilized in drug, OTC, cosmetic, and personal care products include parabens, alcohols, and quaternary ammonium compounds. Antimicrobial Effectiveness Testing (AET) also known as Preservative Efficacy Testing (PET) is microbial challenge methodology performed to assure
On January 1, 2018, USP/NF Chapter 231 on Heavy Metals will be shuttled and new chapters 232, 233 and 2232 on Elemental Impurities will be implemented. What does this mean? It means that the century-old qualitative colorimetric test for the presence of Heavy Metals has been replaced by considerably more sophisticated methods (ICP-OES and ICP-MS)
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics 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 appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers,
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