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).
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.
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.
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 (AMVPMA) and APVMA auditors will provide an update on APVMA expectations, frequently identified issues and changes on the horizon for veterinary medicine manufacture.
This presentation will explore:
• Commonly asked questions related to the cGMP applicable to APVMA license holders.
• What are the Licence holder’s responsibilities and obligations under the existing legislation and
regulation?
• Certificate of Export for Veterinary Medicines.
• Veterinary vaccines using platform technology master files (vPTMF).
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.
This presentation will discuss the requirements for cleanroom design, focusing on the requirements for facilities that want to perform aseptic processes in isolators. It will cover general design concepts regarding layouts, sizing, detailing, HVAC, critical services, controls and alarms. Budgeting and scheduling will also be touched on. Finally, a discussion on the opportunities and hazards of portable facilities. This emerging trend provides significant benefits for some, but not all projects.
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 thought-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.
Analyzing the impact of various forces on our vials during their journey through machinery has always posed a challenge. However, the introduction of new vial drone technology has improved our line operational efficiency. This advancement has led to a reduction in manual interventions, enhanced machine performance, and a decrease in the number of rejected vials, thereby boosting productivity and saving time.
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.
Welcome Remarks by the Moderator
Welcome Remarks by the Moderator
The US FDA published a draft guidance on Inspection of Injectable Products for Visible Particulates in 2021. In the draft guidance, the Agency states that meeting the acceptance criteria outlined in USP General Chapter (790), is not alone sufficient to ensure compliance with the applicable CGMP requirements and full compliance with CGMP requirements is needed to ensure the continued supply of pure, safe, and effective injectable products. This presentation will discuss regulatory expectations on how to develop and implement a visual inspection program and also share case studies on common deficiencies found during regulatory inspections for injectable products.
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
This session provides an opportunity for attendees to discuss key topics or scenarios with challenges in achieving aseptic manufacturing excellence and take away ideas for solutions or clarification on these challenges. Attendees will be given the opportunity to submit topics for discussion prior to the event with the hottest topics to be polled during the session and the most popular topics discussed.
The second of our 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 thought-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.
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.
Welcome Remarks by the Moderator
Speaker: TBC
The information presented at this conference is accurate as of its launch date. However, the organizers retain the right to modify, update, or amend any details as needed. As we aim to provide the most current information and updates, we encourage you to check regularly for any changes.