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Annex 1 GMP Compliance - Exploring 15 Key Topics with High Impact Post-2023

Online Masterclass

  • October 8th - 9th 2024
  • 9.00am – 01.00pm EDT (UTC- 4)

Trainer

James L Drinkwater

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Introduction

With EU GMP & PICS Annex 1 for sterile product manufacturing substantially revised and becoming effective there is a paradigm shift in GMP regulations that all are challenged with implementation With PICS Annex 1: Pharmaceutical Inspection Co- operation scheme involving 56 member countries, including the US FDA, this increases significantly the international significance of this new paradigm in GMP regulations. The new GMP paradigm considers a Holistic, Risk-based (QRM), and proactive approach to contamination control and sterility assurance. This Training covers (15) Topics of high impact and includes a Discussion forum to benchmark with others and understand what is considered as required to meet CGMP Compliance. FDA 483s are now being issued with what is considered an Annex 1 mindset so highly
relevant topics will be discussed.

Key Takeaways

The takeaways for this course address Annex 1 implementation challenges that are considered to be:

Understanding the international relevance of Annex 1 and key principles of this new GMP paradigm.

Understanding the revised Annex 1 requirements as some clauses of the Annex are unclear or open to interpretation. By understanding regulatory intent then interpretation is less likely to be in conflict to GMP inspectors/ auditors’ interpretation.

What’s are the major topics of impact for all Stakeholders.

How to manage the full scope of CCS application applying the QRM principle defined in Annex 1 that extend past sterile drug products to cover intermediates/ substances, APIs and non-sterile products that require bioburden control.

Implementing improved QRM by reworking/ recharacterizing risk assessments to make them less subjective and align with the expectations and new requirements set out in the revised QRM ICHQ9. Understand why ICHQ9 was revised and the significance of the revision.

Introduction of Life Cycle Strategies considering the new Product Life Cycle Strategy ICHQ12. Includes the Life cycle of Environmental Classification, Qualification, Routine Environmental and Process Monitoring (EM & PrM) and re-qualification.

Who Should Attend

  • QA involved in Annex 1 compliance and those facing GMP inspectors and auditors
  • QC (QC Microbiology and Chemistry)
  • Qualified and Responsible Persons (QPs, RPs)
  • Production operations: All levels; supervisors and lead operatives
  • Materials, Science and Technology groups
  • Maintenance leads that support production operations
  • Engineering, Validation and Qualification teams
  • GMP consultants and GMP trainers
  • Process equipment, Barrier Technology designers and manufacturers
  • Contract Manufacturing organizations (CMOs) and Contract Development and Manufacturing organisations(CDMOs)

Meet The Trainer

James, as ex-chairman (for 10 years) and honorary member of the PHSS: Pharmaceutical and Healthcare Science society has followed Annex 1 revision to publication with a role played in
the targeted revision process. The PHSS were appointed by the European Commission (EC) as
one of the twelve (12) appointed commenting platforms in the Targeted consultation phase and James was Co-lead in commenting issued to the EC/ Annex 1 Inspectors Working Group (IWG) via the
PHSS platform. James has also Co-Chaired an Annex 1 discussion forum in London following Annex 1
publication connecting stakeholders to regulatory authorities including MHRA,PICS members,
Ex-Annex 1 rapporteur, and Ex-MHRA GMP inspectors involved in commenting. James is a co-lead
(together with Ex-MHRA Senior GMP inspector) of the PHSS Aseptic processing and Annex 1 focus group and Contamination Control Strategy(CCS) Guidance initiative. In addition, James is currently the Head of GMP compliance for Franz Ziel GmbH the largest Barrier Technology (Isolator and RABS)
and Cleanroom technology manufacturer in Germany. Project involvement includes filling lines
(together with partners) for Pharma and ATMP product applications where increasingly aseptic
processing applies.

James L Drinkwater

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