Cleanliness is a state. Without evidence, it remains a claim.
Industries
The regulations differ, the logic is the same: define the scope, assess the risks, demonstrate suitability. Our focus is the technical infrastructure.
In the manufacture of medicinal products, product quality depends directly on the technical infrastructure. Authorities inspect against the EU GMP Guide, and for the US market 21 CFR Part 211 applies as well. Accordingly, qualification and documentation are examined closely in inspections and customer audits.
In the medical device industry, too, production environments and process equipment must be demonstrably fit for purpose. The regulatory framework differs from pharma, for example ISO 13485 and, for the US market, 21 CFR Part 820, which since February 2026 has referenced ISO 13485 as the QMSR. The logic of requirement, risk assessment and evidence is the same.
GMP laboratories produce the data on which release decisions are based. Besides the analytical instruments, rooms, ventilation and utilities must also be demonstrably fit for purpose.
Contact
You will get a personal reply with a first assessment: what scope makes sense, how we would approach it and which documents you will need.
