Pharmapack 2026: redefining risk in sterile and combination products

Pharmapack 2026 highlighted container closure integrity (CCI) and transport risk as strategic priorities for sterile combination products. Robust CCI is recognised not just as a production control but as a critical sterility assurance factor throughout distribution and end-use.  

The EU Guidelines for Good Manufacturing Practice (GMP) Annex 1 specifies that closure systems must account for transportation and shipping stresses such as decompression and extreme temperatures. 

Traditional qualification often assumes static conditions, yet prefilled syringes and parenteral systems are exposed to repeated pressure changes, vibration and shocks from manufacture through to point of use.  

Even isolated CCI failures can trigger recalls and drug shortages. This risk is particularly acute for oncology medicines, with global cancer incidence projected to rise by around 77%, from an estimated 20 million new cases in 2022 to more than 35 million in 2050.

Chemical risk from materials in contact with the drug product is no longer a secondary concern but has become a strategic driver of regulatory success. Extractables and leachables (E&L) assessments incorporate materials science, pharmaceutical quality and patient safety into early product development.

Nelson Labs applies a risk-based methodology, mapping contact materials, conducting worst-case extractables studies under stress and targeting leachables in representative formulations, aligned with ICH Q3E, ISO 10993-18, European Medicines Agency (EMA) and US Food and Drug Administration (FDA) requirements.

“E&L is not a box-ticking exercise. It is a chemical narrative connecting material selection, analytical thresholds and patient safety,” says Pieter Van Wouwe, Global Director of Analytical Chemistry at Nelson Labs.

The global E&L services market was valued at $1.1-1.3 billion in 2024-2025 and is projected to reach $2.6-4.6 billion by 2034, driven by combination products and high-risk parenteral therapies. Upstream integration of E&L data guides research and development (R&D) material choices and informs quality assurance (QA) and regulatory risk justifications.

Integrating artificial intelligence/machine learning (AI/ML) into GMP environments is transforming manufacturing while introducing new compliance requirements. Regulation (EU) 2024/1689, known as the AI Act, classifies AI used in safety-critical or manufacturing contexts as high-risk and requiring robust risk management, data governance, traceability and human oversight. Draft GMP Annex 22 further addresses AI/ML lifecycle management in active pharmaceutical ingredient (API) and drug product manufacturing.

Patent filings show that major pharma and biotech companies are actively investing in AI for process monitoring, automated inspection and yield optimisation. Pilot projects in GMP environments typically require sixfigure budgets, with some large multisite programmes reported to exceed €1 million in total investment, depending on scope and validation requirements. Reported outcomes from published case studies include 20–25% scrap reduction, up to 47% fewer unplanned line stops and 70–90% shorter batch review cycles, supporting GMP compliance.

“Any AI system involved in a critical manufacturing step must be qualified, validated and embedded into the quality system, with complete traceability of data, models and changes,” says Monika Hupfauf, a legal expert on AI in GMP manufacturing at KOCH/Hupfauf Rechtsanwälte.

Roles are adapting accordingly: R&D define use cases and data strategy, QA build validation frameworks and the regulatory team translate these into Common Technical Document (CTD)-aligned, inspection-ready documentation.

M,aterials, packaging architecture and digital traceability now form a holistic compliance and safety framework. AIMPLAS translates European Pharmacopoeia and US Pharmacopeia monographs into permeability, barrier and migration criteria for polymer-based primary packaging. R&D teams are prioritising compendial polymers, early assessments of humidity, oxygen and gas permeability, and migration risk analysis for inks, adhesives and coatings. 

QA is extending performance validation beyond visual inspection, guided by GMP Annex 1 principles for container closure integrity testing (CCIT) and permeation studies. Anti-falsification measures under the EU Falsified Medicinal Products Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) include seals, shrink bands, void labels, holograms, secure quick response (QR) codes and radio frequency identification (RFID) tags, validated under transport, handling and dispensing conditions. 

Digital traceability complements these safeguards. In a global context where up to 5% of medicines in low- and middle-income countries may be substandard or falsified, embedded Near-Field Communication (NFC), secure chips and distributed ledgers enable real-time verification across the product lifecycle.  

“Digital traceability links physical and data integrity; it enables stakeholders to verify in near real time that a medicine is legitimate, correctly handled and compliant with its intended distribution pathway,” explains Philippe Horcholle, Technical Marketing Engineer for NFC in Europe at STMicroelectronics.

This proactive approach is elevating compliance from a regulatory obligation to a strategic advantage, enhancing patient safety and operational efficiency. End-to-end traceability and rigorously validated packaging underpin QA, market credibility and supply chain resilience. Companies that embed these integrated practices at the design stage are demonstrating that innovation, regulatory foresight and operational excellence are mutually reinforcing drivers of sustainable pharmaceutical development. 

Pharmapack 2026 confirmed that early integration of these principles transforms risk management into a competitive advantage, reinforcing the value of compliance, traceability and validated packaging as pillars of strategic decision-making in modern pharma.