On February 7, 2023, the European Chemicals Agency (ECHA) proposed a manufacturing restriction on a large number of polyfluoroalkyl substances (PFAS). Within this list are PFAS used in manufacturing of some drug products and, in some cases, manufacturing items such as elastomers and films used within the pharma industry. If approved, the restriction on their use would become effective in approximately three to five years, with few exemptions—not even for pharmaceutical manufacturing. In some cases, industry members may be unaware of the impact this proposed restriction may have on their supply chain and/or products. Details on the proposed restrictions can be found here.
The Product Quality Research Institute (PQRI), which PDA is a member of, has developed an industry survey to collect information regarding such restrictions' impact. The information collected will be used in response to the ECHA. More information on the survey can be found here.