CPhI Discover: pharma grows through partnering

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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The last year has been a hugely exiting time for pharma with the industry taking centre stage globally. It’s been a remarkable year of achievements, with the continued production of essential medicines, record levels of innovation and, of course, the discovery, development and commercialisations of multiple COVID vaccines. This success has been founded on an improved era of global collaborations and diverse supply chain partners – which is why CPhI Discover is launching to empower pharma with even more resources to meet, source and discover.

CPhI Discover (17 – 28 May 2021) is an annual online event that combines word-class content and insights with hundreds of virtual exhibitors – and will provide the industry with a new synergistic offering to sit alongside CPhI’s portfolio of in-person events.

This ten-day digital expo will play host to some 13,000+ attendees and over 570 companies, with three days of industry leading content including 20 keynotes, as well as webinars and podcasts, providing key insights from thought leaders. Additionally, CPhI Discover will also include five days of virtual meetings in week two, affording more time to meet greater numbers of potential suppliers, and from anywhere in the world.

If that was not enough, there will also be a range of downloadable on-demand content – including podcasts, webinars and whitepapers – on offer to all attendees. The event spans the entire supply chain, covering every step from R&D and Ingredients to Contract Manufacturing and Pharma Packaging solutions.

“There’s been a subtle shift in the way pharma sources new leads and moving forward, we expect to see pharma companies with the highest growth rates utilising a multi-platform approach, especially as the industry expands and competition for the best partners increases. Practically, this means starting conversations with new customers much earlier and ensuring companies fully maximise the value they get from one of their most precious commodities, the events they attend in person,” commented Cara Turner, Brand Director at Informa Markets.  

Significantly, CPhI data shows 79% of attendees to its previous digital edition – the CPhI Festival of Pharma – had not attended an in-person event before. In fact, digital platforms are expected to sit alongside in person and direct to customer programmes, bringing in new, complementary audiences to the CPhI ecosystem. Additionally, CPhI Discover, thanks to its flexibility in scheduling, also delivers a high proportion of C Suite and above attendees (over 30%) – meaning exhibitors meet the people that matter.

Reimagined Networking & Connecting

In addition to a ground-breaking agenda, CPhI Discover delivers unrivalled networking opportunities before, during and after the show. The ten-day event has been carefully designed with networking at its heart and the second week is dedicated to hosting scheduled meetings between existing and prospective partners.

If you’re in search of a certain pharmaceutical product, ingredient or service and can’t locate the right supplier, let CPhI help you with its reimagined filtering system, designed to ease the labour intensity of preparing for the event. In just a few minutes attendees can create their ideal list of targeted leads to engage with.

“Registration has been augmented to make it as easy and user-friendly as possible in order to best maximise the customer experience. The use of progressive profiling means profiles are built quickly and intuitively so that when the event goes live, you can concentrate solely on meeting partners and watching content. Through the reimagined search tool and dedicated filters, it is now much easier to find the people you are looking to connect with, either at CPhI Discover or later on in the year at one of our in-person events. This type of intelligent hybrid approach, with smart targeting is very much the future of how we will do business in pharma” added Nicola Souden, Brand Manager at Informa Markets.

On-Demand Content Sessions – Market Insights

On-demand presentations will include the manufacturing roadmap of Africa, the impact of the new administration on the US pharma market, outsourcing biologics manufacturing to China and exploring the promise of Latin American (LATAM) Pharma.

Top-line summary of live content sessions – Week 1

Tuesday 18th May

The first day of CPhI Discover is dedicated to manufacturing and outsourcing, with sessions on ‘the CDMO market’, ‘drug development approaches’ to ‘continuous manufacturing’ and ‘sustainability’. This day’s keynote is a live panel discussion, “Navigating the CDMO Market: Hurdles, Transformation & Opportunities” – which will pinpoint the main drivers shaping contract services in a post-pandemic world. The panel comprises Eric Langer, President and Managing Partner, Bioplan Associates, and Peter Shapiro, Senior Director and Editor-in-Chief of PharmSource, part of GlobalData, and Samsung biologics. Rita Peters, Editorial Director, Pharmaceutical Technology and BioPharm International will moderate.

Wednesday 19th May

The second day of CPhI Discover is centred on packaging & drug delivery covering a wide range of issues from ‘cold chain storage challenges’ and ‘track and trace solutions’ to ‘glass packaging solutions’ and ‘autoinjectors’. The day is headlined by a live panel discussion entitled: “Drug Delivery Start-Ups to Watch in 2021 and Beyond”. The session will offer foresight into what the future of drug delivery might hold in terms of regulation, capital raising, and investments. The panel, moderated by Wayne Weiner, Principal, Pharmatech Solutions, comprises Mahmoud Ameri, VP Research & Development at Zosano Pharma, Don Zinn, VP US Business at Crossject and José Ochoa Chief Business Officer at Altimmune.

Thursday 20th May

The final live day of CPhI Discover will focus on APIs, ingredients & formulation exploring everything from the reshoring of the ‘API supply chain’ and ‘nanotechnology challenges’ to ‘plant-based ingredients for cosmeceuticals’ and ‘excipients’. The live panel discussion is on “The API Landscape – Reshoring, Trading & Sourcing Dynamics” and will provide a deep-dive into the API landscape. The complexity of globally interconnected pharmaceutical supply chains, brought into focus by the pandemic, has led to questions about reshoring manufacturing. This live panel discussion will discuss the merits of offshore vs onshore manufacturing and whether reshoring represents an opportunity for boosting innovation and new manufacturing technologies to compete effectively and take a greener approach. The panel, moderated by Aurelio Arias – Engagement Manager – IQVIA, comprises Stefan Schmidinger, Partner, Markets & Business Development, Kemiex and Matt Hicks, Chief Operating Officer & Counsel, Federal Equipment Company.

Key networking features include:

  • No limit on the number of company representatives for each exhibiting company
  • Virtual meetings will be able to host up to 50 people
  • The complete exhibitor list will remain displayed on the Discover website after the show

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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