Good manufacturing practice and FDA regulations require pharmaceutical companies to know their production processes. Understanding the chemicals that potentially could migrate into final products is crucial, particularly for companies that incorporate single-use equipment within their facilities. Manufacturers need to identify which chemicals could migrate and quantify the likelihood of this migration. A forthcoming Parenteral Drug Association (PDA) technical report that recommends a risk-based approach, and pending safety and analytical thresholds from the Product Quality Research Institute (PQRI), will help drugmakers develop appropriate extractables-and-leachables strategies.
The PQRI document
PQRI will submit the final recommendations document to FDA. The document is intended to demonstrate best practices for the evaluation and qualification of leachables in parenteral and ophthalmic drug products. These practices have been extrapolated from the OINDP recommendations, and future documents could potentially address other dosage forms or routes of administration, says Paskiet.
The focus of the PODP document is to demonstrate how to conduct controlled extraction studies to understand the chemistry of the materials and incorporate justifiable safety thresholds. "Our recommendations are to start the selection process during development and begin to qualify components early, rather than in late phases of development, because if you have something objectionable, you can understand the potential to cause patient harm and eliminate or mitigate the risk," says Paskiet.