EU GMP Annex 1 Explained | PIC/S PI 058-1 Q&A (Part 1) | GxP Conversations Ep 26

What does the PIC/S Annex 1 Q&A mean for contamination control in sterile manufacturing? In Episode 26 of GxP Conversations, Kyle Winn and Adam Walker work through PIC/S PI 058-1 and the questions it raises for teams designing, operating and reviewing aseptic processes. In Part 1, we look at what evidence shows that your controls protect the product during routine work, from an operator intervention to a material transfer or a change in the process. - Contamination Control Strategy (CCS) and how to review it when processes or risks change - Cleanroom design, material transfer and the evidence that supports those controls - First air, airflow visualisation and what happens during operator interventions - Isolators, RABS, disinfection and vapourised hydrogen peroxide (VHP) bio-decontamination - Cleanroom classification and routine particle monitoring - Sterilising filtration, PUPSIT and post-use filter integrity testing **Official sources** PIC/S Recommendation PI 058-1 | Annex 1 interpretation Q&A https://picscheme.org/docview/11495 EU GMP Annex 1 | Manufacture of Sterile Medicinal Products https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf **Keep learning with Help Me GxP** Watch Episode 25 for the wider Annex 1 overview https://youtu.be/63GAfCpymFc Search GMP and GDP source documents free with Find Me GxP https://whatisgmp.com/find-me-gxp **Channel sponsor | W² Cleanroom Consulting** W² sponsors Help Me GxP and helps keep our learning resources free. Kyle and Adam support pharmaceutical and aseptic teams with cleanroom projects, contamination control, GMP and GDP audits, hands-on remediation following audit or inspection findings, and Qualified Person (QP), Responsible Person (RP) and RP for import (RPi) support. To talk to Kyle and Adam about your site, visit https://w2cleanrooms.com/ This episode is for education. Use it alongside current official guidance, your approved procedures and formal training. Subscribe to Help Me GxP for Part 2 and more practical GMP, GDP and pharmaceutical quality education. #Annex1 #SterileManufacturing #ContaminationControl #GMP #HelpMeGxP