An Overview of GAMP 5 Second Edition including drivers and objectives, new topics, and updated materials.

Modern tools for developing and managing computer systems are becoming ubiquitous, and in some cases making traditional "compliance" documents redundant. Learn how GAMP 5 2nd edition leverages this in order to maximize efficiency and maintain patient safety, product quality, and data integrity.

The new second edition of GAMP5 provides more than just an update on good practice and facilitating innovative new technologies. It also promotes critical thinking to make validation practices ever more cost effective and efficient. In this presentation learn about the importance of context (seeing the role of the computer system within the broader business process being supported), making better use of supplier activities to reduce duplicated validation effort, and leveraging automated tools alongside the application of science-based risk management.

Combination products are an attractive solution for many patients. Such solutions offer both ease of use in treatment administration and also enable the shift of care administration to the home environment. The available device solutions, however, are few, and include simple mechanical autoinjectors or more complex on-body wearable drug delivery devices. The decision regarding which device to utilize is mainly driven by the volume to be injected, or the drug type. Biological drugs, for instance, are composed of large and sensitive molecules, requiring more sophisticated drug delivery solutions.

While good for patients, combination devices are only chosen for specific clinical situations. This is due to the complexity of these products for all stake holders. This complexity stems from the barriers between patient needs, regulatory approval, human factors expert recommendations, drug and device company’s needs, and the current knowledge available to all.

This presentation will bring to the table the possible technologies and concepts that helps reduce the barriers, time and cost in reaching the market.

Many mission-critical therapeutic solutions may be found in combination products. In this presentation the Agency will provide information to assist industry in its development, application submission, and CGMP compliance of these products. 

Highlights of the recent and evolving regulatory environment that have implications for innovative therapeutic solutions, include: 

• The Genus Court Decision
• The QSR Amendment Proposed Rule 
• FDA Remote Regulatory Assessments (RRA) and how combination products have been impacted 
• De Novo and other recent submission approvals Combination product manufacturing case studies will also be presented, reflecting the impacts of evolving expectations.

As the prevalence of combined-use products continues to grow, the regulatory landscape in this space is increasingly complex. There are, however, common issues and considerations to be addressed across jurisdictions, including systems’ risk-based approaches to development and lifecycle management, ensuring safe and efficacious combined-use of constituent parts, robust collaboration and coordination with suppliers, and sustained market supply for the intended indications. Classification and regulatory constructs for combined-use medical products across jurisdictions are neither stable nor consistent globally. As technology continues to rapidly evolve, harmonization opportunities are evident. Industry needs to exercise caution and be aware of what regulations apply to such combined-use products across jurisdictions.

This presentation will:

• Review the dynamic global combination product regulatory landscape.
• Review harmonization efforts underway, including:
  • ASTM International Combination Product Working Group and Standards
  • FDA Proposed rule on 21 CFR 820 harmonization with ISO 13485:2016
  • WHO
  • ISO 14971:2019 and AAMI TIR 105:2020
  • ISPE Module 2 risk-based QoS Harmonization effort

This presentation will be interactive, engaging the audience to participate by posing questions and asking for their experiences and examples. We start by introducing “the why,” followed with an outline of the regulatory drivers for upgrading a legacy facility, associated consequences, and so forth. 

Following the introduction, we then introduce the business case framework.

• Problem statement: Regulatory issues and their associated consequences are described in detail.
• Scope: Alignment on current portfolio and future capabilities.
• Financials: Robust project financials, especially COGS analysis.
• Socialization: Key stakeholders are included in the development of the story and leveraged when seeking leadership approval.

The session will then apply this framework to a case study.

• Introduce a hypothetical case study (e.g., conventional/legacy filling line).
• Summarize regulatory challenges (problem statement).
• Summarize scope options for upgrading (e.g., upgrade in place, build adjacent, brownfield, do nothing).
• Run the financials for each option.
• Deep dive into the pros / cons / decision points for each option.
• Develop a recommendation.
• Summarize potential socialization plan

The preeminence of mRNA and viral vector-based vaccines in the COVID-19 pandemic response has reshaped the global pharmaceutical manufacturing infrastructure. The speed and scale of investment into manufacturing capacity for these life-saving COVID-19 vaccines has brought these new modalities to commercial maturity in heroic fashion; but in so doing, has also created a massive supply glut with vast implications for manufacturers across the globe. As they seek to simultaneously satisfy current contracts and reposition their production capacity towards products with longer-term demand, manufacturers now face a huge challenge in how best to adapt. 

This presentation will describe the current manufacturing capacity environment, explain the new modalities and the processes involved in their production, and provide a perspective on how the industry can most effectively reallocate capacity and future-proof facilities.

Takeda was the recipient of 2 FOYA awards this year for pharma 4.0 and Supply Chain. In this session, we’ll learn how Takeda approaches and drives innovation during capital project execution. During the execution of both projects, the project teams were presented with a set of unique challenges and needed to consider novel and innovative solutions to deliver on the objectives of both projects. Learn how Takeda overcame these challenges across using novel automation and digital solutions.

We’ll deep dive into some examples from both projects while also covering the cultural considerations which are critical to driving the digital transformation in our industry today.

As COVID-19 started to spread across the world, Johnson & Johnson (J&J) initiated global efforts to develop a potential vaccine against the coronavirus. Soon, successful vaccine candidates were developed. To provide the world with COVID-19 vaccines, J&J needed to increase production capacity. Janssen Biologics, a production facility of biotherapeutics and vaccines in Leiden and part of J&J, was identified to potentially have this capacity. To become one of the main suppliers of J&J’s COVID-19 vaccine, the Vaccines Facility (VF) needed to be expanded at a fast pace.

A project team was installed to build a new, 25,000-square-foot sterile manufacturing facility adjacent to the existing VF. The plans available at the time aimed to expand the facility in five to seven years. However, the current health crisis drove Janssen to develop an enhanced, fast track project plan. The plan aimed for building a brand-new facility and getting it fully operational in twelve months.

These timelines were challenging. But the team did it all within 1 year and 1 day. Hans Weverling, program lead, and James Shovlin, responsible for engineering readiness, will share their key learnings. These learnings include the importance of internal expertise of a dedicated team and an agile mindset, in combination with good collaboration with trusted external partners to bring the best solutions, and efficient cooperation with (local) authorities to pursue all regulatory steps in record time.