Talecris Biotherapeutics Quality And Compliance

The Talecris Melville, NY, facility is an FDA-registered biologics establishment, which operates under U.S. License Number 1716. Our company also holds FDA Biological Licenses for the extraction and purification of naturally occurring proteins.

The facility has been audited every one-to-two years and maintains an excellent compliance record. All product employees receive scheduled training in departmental procedures and current compliance regulations.

Ongoing facility compliance is assured by a rigorous self-audit program, and the company is routinely audited by customers and other regulatory bodies. The quality control operations are certified by the New York State Department of Health.

The following groups contribute to quality systems:

• The quality control laboratories provide high quality product characterization and testing functions that include stability evaluation services.
• The quality audit group identifies, qualifies and maintains surveillance of in-house receiving, testing, shipping, process, and production activities. In addition, this group maintains oversight over external qualified vendors.
• The quality assurance group manages all raw material acceptance and product release, as well as providing general compliance oversight. In addition, this group oversees a robust change control and material nonconformance management system.