What are CHPA member companies doing today to ensure that their medicines measure up to the quality consumers expect?
CHPA member companies continuously monitor the quality and the manufacturing processes of their over-the-counter (OTC) medicines. Companies use science- and risk-based methods to assess the quality of each drug component and of the final product. The methods utilized are based on U.S.-accepted guidelines, guidances, or standards developed by the U.S. Food and Drug Administration or by the U.S. Pharmacopeia. In addition, many companies have adopted international quality guidelines developed by a corroborating body known as the International Conference on Harmonization. Companies also develop internal standard operating procedures (SOPs) to streamline their internal processes to establish an enhanced level of quality.