Course Description:
By now, manufacturers producing sterile drug products for the EU market understand the newest revision to EU GMP Annex 1 is in full effect. While the guidance embraces many current best practices, it introduces the notion that contamination controls should be comprehensive and holistic. For the US market, aseptic products are made under a guidance last revised 20 years ago. The FDA well understands the need to update this aging guidance to best practices and is carefully observing how the Annex 1 revision is being implemented. Annex 1 is an opportunity for industry to emphasize advanced technologies and for Pharma companies to speed up their processes and reduce human error. This webinar will discuss how the now in-vigor requirements impact your organization.
Contamination Control Strategy (CCS):
An overall documented plan to keep your aseptic manufacturing environment under control
Cleanroom:
Understanding the differences between cleanroom classification, qualification, and monitoring
Implementation of new controls:
Pre-use, post-sterilization integrity testing (PUPSIT) of sterile filters and container closure integrity testing of containers
Advanced Technologies:
We will cover “new” technologies like isolators and rigid barrier systems (RABS), single-use systems (SUS) for aseptic processes— including biologics and advanced therapy medicinal products (ATMPs), and closed systems for cell/gene therapy
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biomanufacturing, biologics organizations; Job function: process design, quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.
Though this course is being made available on USP’s
Education site, the course content was developed by Pharmatech Associates, a
USP company. USP has not independently reviewed or verified the accuracy
of the course content.