Education Session

605 - Validating Per Annex 1

Get Agenda 11 November 12.45-15.45
ISPE CEUs: 0.25

Tracks: RegulatoryQuality

Sponsored by the ISPE SPP Community of Practice (COP)

Annex 1 to the EU GMP Guidelines, covering sterile medicinal products, was revised and updated in 2008. The revisions updated four main areas:

  • Classification of environmental cleanliness of clean rooms, and associated text
  • Guidance on media simulations
  • Guidance on bio-burden monitoring
  • Guidance on capping of freeze-dried vials

This session will address the real world implementation of these requirements. What changes from past practices are required for on-going and periodic revalidation of facilities? Case studies from pharma company implementations of the revised guidance for requirements during capping will be discussed.

How you will Benefit

At the end of this session, participants will be able to:

  • Apply knowledge of the changing regulatory environment to validation of sterile pharmaceutical operations in the EU

Who Should Attend

Professionals who are responsible for designing, reviewing, testing, operating, qualifying or validating equipment and systems for sterile pharmaceutical manufacturing

ISPE Communities of Practice (COPs)

C&Q, Containment, HVAC, and SPP

View the ISPE Community of Practice (COP) Guide

Session Leader

Session Presenters

  • Janet Bowen, Dir Compliance/Quality Sys, Commissioning Agents, Inc USA
  • Sterling Kline, R.A., Director, Project Development, IPS USA

Annual Meeting Sponsors