In January, the FDA released the second revision of the Draft Guidance, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” The Agency initially submitted the Draft Guidance in 2014 and followed up with Revision One in December 2018.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
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 It means that the century-old qualitative colorimetric test for the presence of Heavy Metals has been replaced by considerably more sophisticated methods (ICP-OES and ICP-MS)
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