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
Service 02
GMP documentation
Qualification master plan, risk assessment, URS, room book, test plans and SOPs. Every requirement can be traced to its evidence.
What it is about
In an inspection, what counts is what is documented. We create and revise the documents that link planning, risk assessment and testing. We work risk-based in the sense of ICH Q9(R1) and Annex 15: effort and depth follow the risk to product and patient. In our experience this order works well: first decide which objects will be qualified, then assess the risks, and then write the requirements. The URS contains what affects product quality and patient safety. Technical acceptance items without a GMP link are handled separately. That keeps the URS testable and manageable.
Requirements with an origin
Every requirement refers to its source: a regulation, a risk from the assessment or a rule from your SOPs.
A lean URS
The URS contains the GMP-relevant requirements. Purely technical items are tested properly in the technical acceptance.
Consistent across revisions
Consistent IDs, terms and revision status, even while the design is still changing.
Approach
How we work together.
- 01
Review
Review existing documents, design status and the requirements of your quality system.
- 02
Document concept
Define the document chain, numbering, templates and responsibilities.
- 03
Drafting
Draft documents in your templates or in proven structures.
- 04
Review and approval
Align with engineering and QA, incorporate comments, prepare approval.
The document chain
- 01
Master plan
Objects and scope of qualification
- 02
Risk assessment
e.g. FMEA, principles of ICH Q9(R1)
- 03
URS
Requirements with their origin
- 04
Test plans
Acceptance criteria in advance
- 05
Traceability
Requirement to evidence
Sample documents
Structure and level of detail by example.
Unique IDs, acceptance criteria before testing, approval fields and consistent references.
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URS – cover page Sample -
URS – contents Sample -
URS – requirements matrix Sample -
Functional specification Sample -
Design specification Sample -
Risk matrix Sample -
FMEA Sample -
Traceability matrix Sample -
OQ test protocol Sample
All documents shown are fictitious samples in the X-Mon document design. They show layout and structure and contain no customer data and no extracts from regulations. Click to enlarge.
Questions
Frequently asked questions.
Do you work in our document templates?
Yes. If your quality system prescribes templates, we use them. If there are none, we propose a structure you can adopt.
Why does the risk assessment come before the URS?
The risk assessment shows which properties of a system could endanger product and patient. The GMP-relevant requirements follow from that. If the URS is written first, half the bill of quantities often ends up in it, and many items later have to be formally qualified even though they play no role in product quality.
Who approves the documents?
Approval stays within your organisation, usually with QA. We write the documents, check them technically and incorporate review comments.
Can existing documents be revised?
Yes. This often makes more sense than starting again, for example to establish traceability, close gaps or align documents with a modified system.
Insights
Related articles.
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
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
Other services
Contact
GMP documentation: tell us about your project.
You will get a personal reply with a first assessment of scope and approach.