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CPhI Worldwide announces the winners of the 15th Pharma Awards

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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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17 winners chosen from over 250 entries, with Nanobiotix winning both ‘CEO‘ and ‘Pharma Company of the Year’ categories

The 2018 CPhI Pharma Award winner by category:

  • Excellence in Pharma: API Development – Artemisinin, Ipca Labs Limited
    Excellence in Pharma: Formulation – Micelle Inside Solubilisation, MiVital AG
    Excellence in Pharma: Excipients – Parteck® MXP Excipient, Merck
    Excellence in Pharma: Manufacturing Technology and Equipment – AqVida filling line, AqVida GmbH
    Excellence in Pharma: Bioprocessing & Manufacturing – Simplification of Fed-Batch Processes Using Modified Amino Acids, Merck
    Excellence in Pharma: Analysis, Testing, and Quality Control – HyperFlux™ PRO Plus, Tornado Spectral Systems
    Excellence in Pharma: Drug Delivery Devices – e-NOVELIA, the smart ophthalmic add-on,
    Nemera. Highly commended – IQ-Dose, Stiplastics
    Excellence in Pharma: Packaging – Dual-Mix®, TECHNOFLEX. Highly commended – QuickFlip™, Aptar Pharma
    Excellence in Pharma: Supply Chain, Logistics & Distribution – UniSecure®, Systech International
    Excellence in Pharma: Contract Services & Outsourcing – Development of a novel bio-catalysed manufacturing route for a generic API, CatSci Ltd. Highly commended – Continuous Flow Centre of Excellence, Cambrex
    Excellence in Pharma: Regulatory and Compliance Framework, COMPLi– Scientist.com
    Excellence in Pharma: Corporate Social Responsibility – Delivering on the Promise of Good Corporate Citizenship, West Pharmaceutical Services, Inc.
    Excellence in Pharma: CEO of the Year – Laurent Levy, Nanobiotix
    Excellence in Pharma: Pharma Company of the Year – Nanobiotix
    Excellence in Pharma: OTC – Excilor 2-in-1 Wart Treatment Device, Medical Brands and Vemedia
    Excellence in Pharma: Patient Centricity – SRS Unistraw Delivery System, SRS Life Sciences Pte Ltd
    Excellence in Pharma: IT, mHealth & Digitalisation – Qualit-e Cloud, Qualit-e Cloud GmbH

Madrid, 10 October 2018: CPhI Worldwide, organised by UBM (part of Informa PLC), announces the winners of the prestigious 2018 CPhI Pharma Awards. The awards, in their 15th edition, welcomed 365 guests last night to celebrate outstanding achievements in pharma across 17 different categories.

The winner of the award for ‘API Development’ was Ipca Labs Limited for Artemisinin, a new process development that lowers the cost of production to US$100 per kilogramme. The ‘Formulation’ award was given to MiVital AG for its new bioavailability technology, which works by encapsulating lipophilic compounds, making them soluble in an aqueous environment.

Merck received the ‘Excipients’ prize for their Parteck® MXP Excipient that increases the solubility of poorly soluble APIs, so that they can reach a supersaturated dissolution state.

The ‘Manufacturing Technology and Equipment’ award was given to AqVida GmbH for the AqVida filling line – a commercial-scale filling line with robotic arms that saves costs and reduces human interaction.

Merck received a second award for ‘Bioprocessing’ in recognition of its Simplification of Fed-Batch Processes Using Modified Amino Acids. This breakthrough allows for a single, neutral pH feed and results in a more efficient and stable process.

The prestigious ‘CEO of the Year’ award has been presented to Laurent Levy, PhD, the founder and CEO of Nanobiotix who has propelled the company to the forefront of oncological nanomedicine development. Yet the commendations did not stop there with Nanobiotix receiving the award for ‘Pharma Company of the Year’. The company is pioneering new approaches in cancer treatment and fast becoming the leading nanomedicine company.

Tornado Spectral Systems was successful in the ‘Analysis, Testing, and Quality Control’ category for the HyperFlux™ PRO Plus, which permits faster and more sensitive process measurements and enhances spectral throughput.

Nemera received the ‘Drug Delivery Devices’ prize for e-NOVELIAt he smart ophthalmic add-on – it assists in drug delivery and reminds patients when to take their dosage.

TECHNOFLEX won in the ‘Packaging’ category for its Dual-Mix® bag that allows for quicker and safer drug reconstitution. In ‘Supply Chain, Logistics, and Distribution’ Systech International has been commended for its UniSecure® – a supply chain innovation that uses packaging barcodes to create a digital e-fingerprint for product protection.  

The ‘Contract Services and Outsourcing’ award was given to CatSci for the development of a novel bio-catalysed manufacturing route for a generic API, enabling accelerated drug development timelines and lower costs for pharma companies.

Scientist.com was chosen as the winner of the ‘Regulatory Procedures and Compliance’ award in recognition of its new regulatory and compliance framework, COMPLi.

West Pharmaceutical Services, Inc was granted the ‘Corporate Social Responsibility’ award for delivering good corporate citizenship – particularly its recent achievements in environmental sustainability.

Medical Brands & Vemedia was victorious in the ‘OTC’ category for its Excilor 2-in-1 Wart Treatment Device. This is a single streamlined device combining cryo technology and an acid based on TCA-Active.

In the ‘Patient Centricity’ category, SRS Life Sciences won thanks to the Unistraw Delivery System, a child focussed approach to pharmaceuticals and supplements delivery.

Qualit-e Cloud GmbH received the ‘IT, mHealth & Digitilisation’ award for its new web portal. This innovation enables pharmaceutical raw material producers to upload their quality documents and authorise customers and distributors to download.

Tara Dougal, Head of Content – Pharma at UBM, added: “This year has been a truly remarkable and record-breaking year for the pharmaceutical industry and this was definitely mirrored in the extremely high standard of entries at the CPhI Pharma Awards. In our 15th year, we have seen a staggering number of submissions across the pharmaceutical supply chain.

The judges have meticulously assessed each of the entries over all 17 categories and have selected extremely worthy winners. Exemplifying just how difficult a choice it has been – there were too many exceptional entries – the judges felt the need to highly commend several other additional finalists.

On behalf of CPhI Worldwide and UBM, I would like to thank each entrant and sincerely congratulate this year’s winners.”

For more information on the CPhI Pharma Awards please visit: http://awards.cphi.com/

About CPhI
CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, Korea, China, India, Japan, South East Asia, North America, and the Middle East and Africa. Co-locating with ICSE for contract services; P-MEC for machinery, equipment & technology; InnoPack for pharmaceutical packaging; BioPh for biopharma; and Finished Dosage Formulation for every aspect of the finished dosage supply chain.  CPhI provides an online buyer and supplier directory at CPhI-Online.com. For more information visit https://www.cphi.com

About UBM (and parent company Informa)
CPhI is organised by UBM, which in June 2018 combined with Informa PLC to become a leading B2B information services group and the largest B2B Events organiser in the world. To learn more and for the latest news and information, visit www.ubm.comand www.informa.com

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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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