Navigating PIC/S 2026

PIC/S 2026 introduces stricter GMP standards for hospital pharmacies, requiring cleanroom-level compliance for medicinal preparations starting January 1, 2026.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international framework that harmonizes Good Manufacturing Practice (GMP) standards for the production of medicinal products. As of January 1, 2026, hospital pharmacies in Belgium and across Europe will be required to comply with these enhanced regulations. This shift marks a significant change: preparations that were once handled in lab environments must now meet cleanroom standards, with rigorous controls on contamination, documentation, and environmental monitoring.

The goal of PIC/S 2026 is to elevate the safety, quality, and consistency of pharmaceutical preparations in hospital settings. It aligns hospital pharmacy practices with the same high standards applied to industrial drug manufacturing, ensuring better protection for patients and more robust contamination control across the board.

From lab to cleanroom

As PIC/S 2026 approaches, hospital pharmacies across Belgium are facing a pivotal shift. During recent sessions with pharmacy teams, one thing became clear: the need for practical, hands-on support is greater than ever. Theoretical knowledge alone isn’t enough. Pharmacists are seeking real-world strategies to move confidently from lab-based environments to fully compliant cleanrooms.

Key takeaways for a smooth transition

Implementing PIC/S norms requires more than ticking regulatory boxes. It demands a proactive mindset and attention to operational details that directly impact contamination control and patient safety.

• Start early: PIC/S rules apply as soon as your installation is classified, even before production begins. Early compliance planning is essential.
• Prioritize risk assessment: Deviations from standard protocols are possible, but only when backed by thorough, documented justification.
• Embrace inspections: Audits are learning opportunities. Inspectors are also adapting to the new norms, and their feedback can be invaluable.
• Train and document: Cleaning staff should be trained regularly, with clear documentation. Avoid overcrowding cleanrooms during training to prevent unnecessary re-cleaning.
• Begin with worst-case frequencies: At start-up, adopt conservative cleaning and disinfection schedules. Adjust based on environmental monitoring data over time.

These changes aren’t minor operational tweaks, and you don't have to navigate them alone. Expert guidance, shared best practices, and tailored advice can make the transition smoother and more confident. Together, we can ensure GMP compliance, safeguard patient health, and maintain efficient pharmacy workflows.

Cleanroom consumables, contamination control protocols, and staff behavior all play a role in meeting the new standards. Support is available to help you meet PIC/S requirements with clarity and control.
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