Articles
RSSPall Corp. Announces Strategies to Comply with New FDA Initiatives on Aseptic Processing and GMP
October 21, 2003
Martin's presentation highlights the importance of leveraging equipment supplier expertise and services to validate a range of devices and processes according to these new FDA Guidance Documents. Pre-sterilization of disposable systems is one approach biopharmaceutical manufacturers can take to streamline compliance for drug development. Martin's presentation highlights performance studies in which validation procedures were simplified by using disposable methods.
FDA's draft guidance on aseptic processing provides broad recommendations on the manufacture of sterile drug and biological products. Martin describes several key areas where equipment suppliers can facilitate a biopharmaceutical manufacturer's compliance, including:
- Sterilizing filtration validation
- Automated equipment qualification
- Aseptic connection devices and single use process system validation
"Pall is a leader in facilitating validation compliance for biotechnology and pharmaceutical companies. Our expertise in disposable processing methods is invaluable in light of these new FDA guidelines," says Jerry Martin. "Biopharmaceutical manufacturers can facilitate regulatory compliance, maximize resource utilization and expedite new product introductions by availing themselves of outsource services available from broad-based equipment suppliers such as Pall."
Pall Corporation provides contract process development, optimization, filtration validation and other consulting services to the biopharmaceutical industry. Pall's automated process systems and test equipment, aseptic connection devices and disposable single use filtration systems are supplied with pre-validation documentation that minimizes user validation requirements.
Martin's presentation, entitled Incorporating Supplier Validation Data and Services to Facilitate Compliance, is part of the Adopting Regulatory Initiative panel today at biologic USA 2003, held at the Radisson Hotel in Boston, MA. The panel's keynote presentation is being given by Dr. Lester M. Crawford, DVM, Deputy Commissioner of FDA.
