Contact

Checklist: Are you ready for the new PIC/S standards?

by | May 19, 2025 | News

Share

Checklist: Are You Ready for the New PIC/S Standards?

News

PIC/S Compliance

1 January 2026. That’s the deadline for your cleanroom to comply with the new PIC/S guidelines, at least if you are involved in pharmaceutical production. The objective? Harmonising and improving regulatory frameworks and inspection procedures across the pharmaceutical sector.
In this blog, we offer a practical checklist. The more boxes you can tick, the better prepared you’ll be.

For those unfamiliar: PIC/S stands for the Pharmaceutical Inspection Co-operation Scheme,  a global network aimed at strengthening quality standards, patient safety, and regulatory compliance in pharmaceutical manufacturing.
The new standards focus on hygiene, contamination control, risk management, validation processes, and quality assurance.

Vaccinopolis

Our PIC/S Compliance Checklist for Cleanrooms

1. Up-to-Date Knowledge of the New Guidelines

  • Are your employees informed about the latest PIC/S changes?
  • Have you organised internal or external training sessions to implement the updates?
  • Are you aware of the new documentation requirements?

2. Validation and Documentation

  • Have all processes been revalidated according to the updated guidelines?
  • Are all critical parameters being monitored and recorded accurately?
  • Are all Standard Operating Procedures (SOPs) updated and documented?

3. Cleanroom Design and Classification

  • Does your cleanroom comply with current ISO 14644-1 standards?
  • Are airflow and ventilation systems aligned with the new PIC/S requirements?
  • Is a proper pressure cascade system in place to prevent contamination?

4. Personnel and Hygiene Procedures

  • Are all staff trained in the latest hygiene and gowning protocols?
  • Are there strict procedures for entering and exiting the cleanroom?
  • Are microbiological controls on personnel and surfaces regularly conducted?
Vaccinopolis

5. Material and Product Flow

  • Is your logistical flow optimised to prevent cross-contamination?
  • Are raw materials and finished products stored correctly according to the new guidelines?
  • Are there sufficient airlocks and transfer systems to control the movement of goods?

6. Monitoring and Environmental Control

  • Is there continuous monitoring of air quality and particle counts?
  • Are temperature, humidity, and pressure differentials being tracked at all times?
  • Have cleaning and disinfection protocols been optimised?

7. Risk Assessment and Deviation Management

  • Have you conducted new risk analyses based on the latest PIC/S standards?
  • Is there an up-to-date Corrective and Preventive Action (CAPA) system in place?
  • Are audit and inspection results used to drive continuous improvement?

Tailored advice

Need support to ensure your facility is PIC/S-ready?

Get in touch with Jansen Cleanrooms & Labs for expert guidance tailored to your needs.