Qualification
Temperature mapping of storage areas and cold rooms
Why warehouses, cold rooms and climatic chambers are mapped, how measuring points, duration and load are defined, and what EU GDP, EU GMP and WHO say.
· 8 min read
Insights
Articles for engineering, QA and project management.
Practical guidance on the documents and steps that keep raising questions in technical GMP projects.
Qualification
How risk assessment determines the scope of qualification
How a risk assessment based on ICH Q9(R1) principles defines what is qualified and how deeply. With examples from cleanrooms, HVAC and pharmaceutical water.
· 5 min read
Qualification
The room book as the basis of room qualification
What belongs in a room book, how it leads to the air volume schedule, and where the qualification interface between the room and the HVAC system lies.
· 8 min read
Documentation
What belongs in a URS, and what does not?
A URS should remain testable. Why we recommend including only GMP-relevant requirements and how to keep technical acceptance points cleanly separate.
· 5 min read
Audit
Audit preparation for technical GMP projects
Audit preparation for technical GMP projects: document map, URS to qualification, CAPA, calibration, maintenance and walkthrough, with a checklist.
· 7 min read
Documentation
Common errors in GMP documentation
Common errors in GMP documentation: why they stand out in audits and how to set up requirements, traceability, approvals and raw data properly.
· 7 min read
Qualification
DQ, IQ, OQ and PQ explained
DQ, IQ, OQ and PQ explained: objectives, test points and evidence for each qualification stage, with practical examples from cleanrooms, HVAC and compressed air.
· 9 min read
Regulatory
EU GMP Annex 1: what it means for technical systems
EU GMP Annex 1 and technical systems: what the revised version means for cleanrooms, HVAC, monitoring, utilities and barrier systems, with a gap analysis.
· 8 min read
Qualification
Traceability matrix: purpose, structure and practice
Traceability matrix in GMP: purpose, structure from URS to IQ/OQ/PQ, an example table, maintenance through changes and common pitfalls in qualification documentation.
· 7 min read
Documentation
What is a URS in a GMP environment?
URS in a GMP environment: purpose, typical content and testable requirements. How user requirements become the basis for specification, qualification and audit.
· 8 min read
This content is for general technical guidance and does not replace a project-specific GMP assessment.
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