Good Manufacturing Practices (GMPs) have significantly evolved over time into the current GMPS (cGMPs) we have today, in order to ensure the safety, quality and efficiency of pharmaceutical products. In the beginning GMPs took shape in response to public health tragedies caused by contaminated or poorly manufactured drugs, highlighting the need for rules around manufacture in order to protect the patient. The next major step in evolution to cGMPs resulted from efforts to harmonise GMP standards across the differing global markets. Changes reflect the industry ongoing commitment to ensuring patient safety through the provision of quality products.

How have these changes shaped cGMPs for drug manufacture and how do we achieve aseptic manufacturing excellence in accordance with cGMPs and the requirements of Annex 1 for the Manufacture of Sterile Medicinal Products? These questions will be explored throughout the program beginning with this plenary session featuring Andy Hopkins who was instrumental in drafting the latest revision to Annex during his time with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

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  Andy Hopkins

  Senior Director of Lachman Consultants

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  Brent Lieffers

  Senior Director of Innovation Advocacy at Cytiva
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  Andy Hopkins

  Senior Director of Lachman Consultants
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  Lisa Bennett

  Director of LB Consulting Australia

Efforts with global harmonisation in GMPs began over 40 years ago with significant contributions from organisations such as the World Health Organisation (WHO), The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Cooperation on Harmonisation (ICH).

Regulatory agencies have long been collaborating to keep up with the demands of the global pharmaceutical industry by fostering opportunities for communication and collaboration by establishing initiatives such as Mutual Recognition Agreements (MRAs) to streamline regulatory oversight.

The International Coalition of Medicines Regulatory Authorities (ICMRA) have been working on further collaborative indicatives with their Pharmaceutical Quality Knowledge Management (PQKM) Pilot Programmes including the Collaborative Hybrid Inspection Pilot (CHIP). With the last of three hybrid inspections executed in May 2024 representatives involved on both sides of the proverbial fence will share their experiences.

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  Peter Qiu

  External Advocacy Lead, APAC at Roche Genentech

This presentation gives an overview about the ICMRA’s Collaborative Hybrid Inspection Pilot (CHIP) from the Industry’s Perspective. The CHIP provides an opportunity to reach agreement from multiple authorities on the compliance of a site with a single inspection activity.
This presentation illustrates a companies’ journey in preparing, organising and hosting a CHIP inspection performed jointly by multiple authorities under the lead of an on-site inspectorate. It talks about the challenges, opportunities and benefits of the CHIP and ultimately how such pilot can further support reliance and convergence efforts.

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  Andrea Kurz

  Senior Director, External Advocacy Europe and Middle East of F. Hoffmann-La Roche Ltd

The regulation of veterinary medicine manufacture still varies globally despite efforts to harmonise GMPs by regulators and global organisations such as the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the Veterinary International Conference on Harmonisation (VICH). Variations in the way regulatory agencies classify and regulate veterinary medicines create further challenges with efforts on harmonisation.

Representatives from the Australian regulator the Australia Pesticides Veterinary Medicine Manufacture (APVMA) and APVMA auditors will provide an update on APVMA expectations, frequently identified issues and changes on the horizon for veterinary medicine manufacture.

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  Justine Mann

  Chief Executive Officer at CBE Pure Solutions

The veterinary GMPs have been evolving over the last 25 years with a careful balance between full compliance and what’s achievable by manufacturers. There is an enormous diversity in the industry from farm sanitants, to lick blocks and feed supplements to high end sterile injectables and vaccines. The APVMA auditors generally adapt their code GMP expectations based on practical control and product risk to the patient/animal while ensuring companies at all times operate within the Manufacturing Principles and basic GMPs.

This presentation provides a window into some of my experiences using some case examples and also outlines the current framework veterinary medicines auditors and APVMA work within.

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  Steve Williams

  Director of SWA Biopharm P/L

Discover how CAI's Operational Readiness Model can help you to achieve full-scale operations on time and within budget with all your workstreams at peak performance, turns the inevitable issues in every capital project into identified risks which are then mitigated during project delivery, resulting in meeting market demand upon startup.

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  John Wrenn

  Country Manager, Australia & New Zealand at CAI Australia Pty Ltd

Contamination Control Strategy - it all starts with good cleanroom design. Manufacturing facilities should be appropriately designed to protect medicinal products from potential sources of endotoxin/pyrogen, particulate and microbial contamination. Eudralex / PIC/S Annex 1 encourages the use appropriate barrier technologies such as isolators to increase protection of the product from such contamination. The separation of product from some of the highest risks present in a cleanroom (yes you - people!) creates opportunities and challenges for our aseptic operations. This session will explore some of these opportunities and challenges along with how our cleanroom design might change to accommodate the use of isolator technology.

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  Jo Sherriff

  Engineering Compliance Manager at SeerPharma Pty Ltd

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  Brent Lieffers

  Senior Director of Innovation Advocacy at Cytiva

This is the first of two case study sessions providing an opportunity for companies to share a new process or technology they have successfully implemented, whilst often applying problem solving skills, navigating challenges and learning from mistakes.
Whether it be the use of data analytics, technologies or automating processes these implementations help to achieve manufacturing excellence.
These though provoking case studies provide an opportunity for contextual learning from others, whom we guarantee you’ll want to talk further with during the afternoon break immediately following the session.

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  Nadia Seidel

  Site Operational Excellence Lead at Pfizer

The regulatory requirement for Pre Use post Sterilisation Integrity Testing (PUPSIT) has been with us now for many years. The recent review and release of EU GMP Annex 1 has re-focused attention on PUPSIT for many Regulators, Auditors and ultimately manufacturers. This case study will look at the implementation of PUPSIT in a single use process setting with automation.

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  Micheal Schafferius

  Application Specialist for Separation Technologies and Quality at SARTORIUS
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  Hai Tran

  Senior Manufacturing Area Manager – HS&S Filling at CSL Behring

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  Daniel Klein

  Senior Manager, Technical Services at STERIS

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  Daniel Klein

  Senior Manager, Technical Services at STERIS
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  Kim Sobien

  Senior Microbiology Consultant at ValSource
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  Mylinh La

  Senior Lab Manager at CSIRO

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  Kim Sobien

  Senior Microbiology Consultant at ValSource

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  Justine Mann

  Chief Executive Officer at CBE Pure Solutions
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  Sadman Bhuiyan

  Project Manager, Scientist and Educator at Inoviq Limited

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  Kim Sobien

  Senior Microbiology Consultant at ValSource

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  Daniel Klein

  Senior Manager, Technical Services at STERIS
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  Kim Sobien

  Senior Microbiology Consultant at ValSource
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  Fergus O'Connell

  Head of Quality - AU/NZ at Eurofins ams Laboratories

Contamination of parenteral injections is a patient risk factor that should be understood, analysed and controlled. Contamination, whether it be microbial or particulate, combined with the route of administration determines the severity of potential resulting adverse events. It is crucial that we have control strategies in place during product manufacture to mitigate the occurrence of such contamination and preserve the purity and integrity of parenteral products for the length of their shelf life.
Drug products for parenteral administration should be "practically free" or "essentially free" of visible particles and their containers integral to preserve the sterility of the product.
Annex 1 prescribes the use of visual inspection of filled containers by validated methods using a scientifically justified approach. This session will explore the US FDA guidance on the inspection of parenteral products and explain some of the science around container closure integrity testing methods given that visual inspection is not considered as an acceptable integrity test method.

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  Sadman Bhuiyan

  Project Manager, Scientist and Educator at Inoviq Limited

This presentation discusses the regulatory landscape surrounding Container Closure Integrity Testing (CCIT). I will delve into Annex 1, highlighting the recent updates and its regulatory significance. We will explore how regulations shape CCIT strategies and the application of various CCIT methods throughout a product's lifecycle. The discussion will cover critical factors to consider when selecting appropriate methods at different stages of the product lifecycle. By providing a detailed understanding of these aspects, the presentation aims to guide manufacturers on container closure integrity testing in strict compliance with regulatory standards

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  Anthony Georgiadis

  Sales Director of Amscorp Scientific

During this session our we will discuss hot topics and challenges with aseptic manufacturing.

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  Daniel Klein

  Senior Manager, Technical Services at STERIS
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  Brent Lieffers

  Senior Director of Innovation Advocacy at Cytiva
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  Andy Hopkins

  Senior Director of Lachman Consultants
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  Peter Qiu

  External Advocacy Lead, APAC at Roche Genentech
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  Michael Edey

  Senior Principal Engineer at Pfizer
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  Kim Sobien

  Senior Microbiology Consultant at ValSource

Do you find yourself with the laborious task of creating the same report week after week, month after month?  Rather than traditionally relying on external IT resources to create intricate automated reports, Microsoft Power Platform is an easy and intuitive tool that can be used by anyone who is experienced in standard Microsoft tools (particularly Excel). This is what is currently in use at CSL Behring, Broadmeadows. This presentation will cover how Power BI and the Microsoft Suite of tools can work together to easily transform raw data into actionable insights that the most basic users can navigate. Microsoft Power BI data flows can be used to share datasets with efficiency and without IT expertise, and allow us to gain control of reporting metrics by creating “One Source of truth” within large scale Pharmaceutical Enterprises.

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  Tanvi Maturi

  CSL Behring

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  Tanvi Maturi

  CSL Behring
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  Craig Stephens

  Senior Director Quality of CSL Behring (Australia) Pty Ltd
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  Robyn Hofer

  Operations Manager at CBE Pure Solutions
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  Riley Fitzpatrick

  Senior Microbiologist BSc at CBE Pure Solutions

Good Manufacturing Practices (GMPs) have significantly evolved over time into the current GMPS (cGMPs) we have today, in order to ensure the safety, quality and efficiency of pharmaceutical products. In the beginning GMPs took shape in response to public health tragedies with the next major step in evolution resulting from efforts to harmonise GMP. What will be the catalyst for change in the future? Further regulatory convergence? Sustainability and environmental impact? Digital transformation and Industry 4.0? Another pandemic? Or just more tragedies highlighting additional controls required.

We will hear from current and former regulators on their thoughts about how they see cGMPs evolving in the future for the manufacture of human and veterinary medicinal products.

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  Lisa Bennett

  Director of LB Consulting Australia