2023 PDA Annex 1 Workshop (Raleigh)

08:00 – 09:30 | P1: Overview of and Revision Process for Annex 1
Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company

Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. The revised Annex 1 contains a significant amount of new and more detailed content on many topics. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes.

10:00 – 11:00 | P2: Scope, Principles and Pharmaceutical Quality Systems
Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company

This session opens our in-depth look at the content of the draft Annex 1. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. This session will also address the expanded scope of Annex 1 to include some non-steriles.

11:00 – 11:45 | Breakout Session 1

13:00 – 14:00 | P3: Premises and Barrier Systems
Moderator: Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company

Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1.

14:00 – 14:45 | Breakout Session 2

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems.

15:15 – 16:15 | P4: Equipment, Technology, and Utilities
Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

This session will discuss the impact of the Annex 1 revision on aseptic manufacturing facilities, specifically focusing on equipment design, indirect product contact parts, such as stopper bowls, and critical utilities, such as water systems.

16:15 – 17:00 | Breakout Session 3

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities.

08:00 – 09:00 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
Moderator: Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, ValSource, Inc.

Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy.

09:00 – 09:45 | Breakout Session 4

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment.

10:15 – 11:00 | P6: Production Technologies, Part 1
Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success.

11:00 – 11:45 | Breakout Session 5

13:00 – 13:40 | P7: Production Technologies, Part 2
Moderator: Tracy Moore, Director, TM Pharma Group Ltd

This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions.

13:40 – 14:30 | Breakout Session 6

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P7: Production Technologies, Part 2 (Container Closure Integrity Testing and Finishing and Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization).

15:00 – 16:30 | P8: Aseptic Process Simulation and Environmental Monitoring
Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process.