Discussion forum moderators:

Di Morris PHSS Co-Chair, James Drinkwater (Ex-Chairman, honorary member)

• Objectives of the Annex 1 discussion forum and intended outcomes
• Overview of key updates in Annex 1 from version v12 that was the subject of a targeted consultation process with PHSS as one of the (12) EC appointed Targeted commenting platforms through to the final publication on 25 August 2022 that goes a long way to addressing industry concerns, but still issues of clarity remain.
• Insight to how the discussion forum will be managed.

Important Quality related concepts that are fundamental to the revised Annex 1

• The paradigm shifts in GMP regulations to Risk based, holistic and proactive methodologies and international relevance of Annex 1.

• Risked based with QRM as a fundamental principle

• Holistic considering collective effectiveness of control measure across interrelated areas and operations.

• Proactive with data-based knowledge, trending and reviews that drive improvements over the product Life cycle (ICHQ12).

Discussion sessions

• Contamination Control Strategy (CCS) insight to expectations and PHSS guidance to assist preparation.

Break for refreshments

• Session 1: Annex 1 sections 1; Scope, 2; Principle, 3; Pharmaceutical Quality System (PQS).

Break for Lunch

• Session 2: Annex 1 sections 4; Premises, 5; Equipment, 6; Utilities

Short break

• Session 3: Annex 1 sections 7: personnel, 8: Production and specific technologies

Afternoon Break

• Session 4: Annex 1 sections 9; Environmental and process monitoring, 10: Quality Control, Glossary

 Thanks, closing statement and discussion close.