Since the revised EU GMP Annex 1 became effective on 25 August 2023, and with PIC/S PE 009-17 aligning the same expectations across participating authorities, many organisations are facing the same recurring questions:
- Which contamination control requirements actually apply to our processes – and how do we evidence them?
- How do we keep cleanrooms, procedures and monitoring programmes compliant between qualifications, not only on the day of testing?
- What documentation, risk assessments and qualification strategies do inspectors actually expect to see?
- How do we deliver all of this without stopping production?
This isn't only an industrial concern. Hospital pharmacies and compounding centers face a parallel shift under PIC/S PE 010-4, the guide for preparing medicinal products in healthcare establishments. In Belgium, it became binding for hospital pharmacies from 1 January 2026 under the Royal Decree of 30 September 2020, with FAGG inspectors assessing compliance directly. The same questions above apply here too, even outside the industrial GMP framework.
Effective contamination control goes far beyond testing. Annex 1 makes this explicit through the Contamination Control Strategy (CCS): a single, facility-wide strategy in which design, qualification, cleaning and disinfection, environmental monitoring, personnel behaviour and process controls are shown to reinforce each other. Individually compliant elements are no longer sufficient; the connection between them is what is now inspected. Delivering that in practice requires an integrated approach covering project management, documentation and procedures, risk-based test strategies, qualification and validation activities, test execution, data trending and ongoing monitoring.
Within the Normec group, we support pharmaceutical and biotech organisations with end-to-end contamination control – helping them stay compliant, inspection-ready and operationally efficient.
Our expertise includes:
- Cleaning and disinfection qualification – demonstrating that cleaning and disinfection procedures are effective on your surfaces, against your own environmental isolates
- Cleanroom qualification and periodic requalification – airflow, pressure cascades, installed filter leakage testing, recovery and overall facility performance, at the intervals required by Annex 1 (maximum 6 months for grade A/B, 12 months for grade C/D)
- Routine environmental monitoring – viable and non-viable monitoring, isolate identification and trending, to detect deviations and emerging risks early
- Contamination Control Strategy – development, gap assessment and periodic review, connecting the elements above into one defensible strategy
By integrating these processes, we help organisations do more than meet regulatory expectations: we help them reduce contamination risk and build a contamination control strategy that holds up across the full lifecycle of their facilities and processes.
Working in QA, QC, manufacturing or validation in pharma, biotech, or hospital pharmacy? Over the coming weeks we are publishing a six-part series on contamination control – cleaning and disinfection qualification, cleanroom qualification, routine environmental monitoring, human behaviour and a case study from a live cleanroom qualification project.
Need support putting this into practice? Explore our Cleanroom Validation and Environmental Monitoring and Commissioning, Qualification, and Validation (CQV) services, build internal expertise with our Contamination Control Strategy training, or manage your documentation and CAPAs digitally with QFacts eQMS.
About Normec Advipro
Normec Advipro ensures that your organization in life science operations complies with regulations while also maintaining sustainable compliance. With our expertise in GMP, ISO standards, the FDA, the EMA, and other regulatory bodies, we implement smart solutions that ensure regulatory compliance and improve operational efficiency. From project initiation to periodic requalification: we support you at every stage to ensure optimal performance and risk management.
About Farma Consulting
Farma Consulting & Partners aims to be the reference for QA, QP, qualification and validation activities within the life sciences sector. We build sustainable, long-term relationships with our clients, with one goal: bringing your products to market safely, and implementing, optimising and validating your quality system efficiently. We continuously challenge the status quo. In a strictly regulated pharmaceutical sector, processes and systems are often approached conservatively — with our expertise in the applicable regulations, we are committed to helping our clients operate in the most efficient way possible.
Learn more about our services:
