December 2003

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and analytical issues despite early regulatory guidance. Review key risk points in analytical and tech transfer to better ensure commercial readiness.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.