USP Overview and Some Current Activities

USP Overview and Some Current Activities
Anthony DeStefano, Ph.D. Senior Vice President, Compendial Science, USP

Aseptic Processing of Biological Products: Current Regulatory Issues “Facing the Challenges of Drug Product Manufacturing”

Aseptic Processing of Biological Products: Current Regulatory Issues “Facing the Challenges of Drug Product Manufacturing”

Aseptic Processing of Biological Products: Current Regulatory Issues

“Facing the Challenges of Drug Product and Device Development & Manufacturing”
Patricia F. Hughes, Ph.D. Branch Chief (Acting) FDA/CDER/OPQ/OPF/DMA/BIV
WCPB 2016 January 27, 2016 Washington, D.C.

Evaluating Pharmaceutical Container Closure Systems

The use of qualitative and quantitative methods can help packaging professionals determine the presence of extractables and leachables.
David E. Albert, NAMSA (Northwood, OH)
The United States Pharmacopeia (USP) and FDA have been and continue to be the driving force behind the safety evaluation of materials and container closure systems in the United States. An important step in such evaluations is characterizing the materials and the chemicals that can migrate or extract from container closure system components to the drug product. Figure 1 shows the various types of chemicals that can migrate from polymeric materials1. Such basic information is critical to understanding the biological safety and suitability of a container. A number of tests can be used to establish initial qualification of the container closure system, and a quality control plan can help ensure compatibility and safety.

Single-Use (SU) Container Closure Integrity (CCI)

Regulatory & Industry Requirements
SSB Position Statement on SU-CCI
Quality Risk Management, Process Validation and QC
Supplier bag chamber leak test and Integrity Testing
Pre Use Leak Testing for Flexboy®
Conclusions