Pharmaceutical Excipients: Criticality and the Need for Rigorous GMP audits

Synopsis

Pharmaceutical excipients, often constituting a significant portion of drug formulations, carry a high risk of introducing contaminants directly into medications due to adulteration or contamination, with potential repercussions on patient health as these impurities are challenging to detect. Furthermore, excipients frequently play a vital role in the bioavailability of drugs. It’s imperative, therefore, to analyze the criticality of each excipient used and specifically audit those deemed critical to ensure adherence to Good Manufacturing Practices (GMPs), thereby upholding the quality of medications.