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
Service 03
GMP consulting
Joining running projects, Annex 1 gap analyses and audit preparation. At the end you know where you stand and what to do next.
What it is about
We are often brought in when the design work is already under way. Construction, installation and qualification overlap, and documents exist in different revisions. We check the existing requirements against your SOPs, the design documents and the requirements of the EU GMP Guide and 21 CFR Part 211. That includes a look at actual use, which quite often differs from what the documents say. You receive a findings list with three clear categories: met, conflict, not evidenced. Every action is prioritised and has an owner.
Specific findings
Every gap is evidenced and rated by risk. No general remarks without a reference.
Actionable measures
Every recommendation is tied to a document, a system or an owner.
Engineering and QA together
We translate between technical design and regulatory expectations.
Approach
How we work together.
- 01
Objectives
Agree on the reason, scope and assessment criteria.
- 02
Review
Review documents, walk through the facility, talk to engineering, users and QA.
- 03
Comparison
Check every requirement against design and actual status and rate it.
- 04
Action plan
Hand over prioritised actions with owners and sequence.
Joining a running project
- 01
Review
Design, BoQ, drawings, customer SOPs
- 02
Comparison
Requirements against GMP expectations
- 03
Walk-through
Documents against actual use
- 04
Findings list
met, conflict, not evidenced
Questions
Frequently asked questions.
Can you join in the middle of a project?
Yes, that is actually the most common case. We start with the existing documents and the current design status. What already works stays as it is.
Do you take on full computerised system validation?
We cover CSV and GAMP 5 at advisory level: classification, categorisation, documentation scope, requirements from Annex 11 and 21 CFR Part 11 and the interfaces to equipment qualification. For extensive software validation we recommend specialist partners.
Is a gap analysis useful without an upcoming audit?
Yes, for example before a new build, before extending a system or after a regulation such as Annex 1 has been revised.
Is this legal advice?
No. We provide technical GMP consulting. Responsibility for regulatory decisions stays with your organisation.
Insights
Related articles.
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Audit preparation for technical GMP projects
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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.
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Other services
Contact
GMP consulting: tell us about your project.
You will get a personal reply with a first assessment of scope and approach.