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Qualification
DQ, IQ, OQ and PQ for cleanrooms, HVAC systems, compressed air, pharmaceutical water and process equipment. We derive the test scope from the risk assessment.
GMP qualification · Pharma · Medical devices
Qualification that holds up in an audit.
We plan and document the qualification of cleanrooms, HVAC systems, compressed air and pharmaceutical water. Since 2013, for pharma, medical devices and GMP laboratories in Germany, Austria and Switzerland.
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2013
founded, based in Leonberg
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DQ to PQ
plan, protocol and report
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DACH
on site and remote
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Independent
not tied to any manufacturer
Our principle
Cleanliness is a state.
Without evidence, it remains a claim.
That is why we back every requirement with a test step, a measured value and a signature. What is in the room book shows up in the protocol, and what is in the protocol can be shown in an audit.
Services
From qualification plan to approval.
Three services that work together. We add calibration where measured values feed into qualification.
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GMP documentation
Qualification master plan, risk assessment, URS, room book, test plans and SOPs. Every requirement can be traced to its evidence.
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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.
Additionally: Calibration & measurement for quality-relevant instruments and sensors, with traceable references.
How we work
First the plan, then the risk, then the requirement.
Under Annex 15, the scope and depth of qualification follow a documented risk assessment, and ICH Q9(R1) provides the methodology. That is why we put into the URS what affects product quality and patient safety. Everything else we test in the technical acceptance.
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QMP
Define objects, interfaces and scope
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Risk assessment
shows what is critical for product and patient
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URS
GMP-relevant requirements only
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DQ
User requirements against supplier specification
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IQ · OQ · PQ
Expected against actual, with evidence
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Approval
Report, then requalification
DQ as a comparison
The user requirements describe what you need. The supplier specification describes how the supplier will deliver it. The DQ checks whether the two match.
Room book as the basis
For rooms, the room book holds the quality-relevant data. It is the basis for the DQ and leads to the air volume schedule and the ventilation schematic.
Clear interfaces
We define in the qualification plan where the room ends and the HVAC system begins. In the OQ both come together, and every test appears exactly once in the right protocol.
Systems
What we qualify.
Our focus is the technical infrastructure: everything that affects product quality through rooms, air, water and utilities.
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Cleanrooms
Grades A to D to Annex 1 or ISO classes to ISO 14644-1, room book as the basis for the DQ, room OQ for airlocks and interlocks.
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HVAC systems
Air volumes, pressure cascade, airflow direction, filter integrity, temperature and humidity.
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Compressed air and gases
Purity to ISO 8573-1 at points of use with product contact.
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Pharmaceutical water
Purified Water and WFI to Ph. Eur.: generation, storage and distribution.
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Storage areas and cold rooms
Temperature and humidity mapping of warehouses, cold and freezer rooms, refrigerators and climatic chambers.
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Process equipment
Equipment with product contact, instrumentation, alarms and safety functions.
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Laboratory areas
Rooms, ventilation, fume hoods and utilities in GMP-regulated laboratories.
Test depth based on risk.
How deeply we qualify depends on the cleanroom grade and the impact on the product. Our initial proposal is confirmed in the project by a risk assessment and agreed with your QA.
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Grade A / B
Aseptic areas
Full scope from DQ to PQ for room and HVAC system, with airflow visualisation, recovery time and microbiological tests to Annex 1.
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Grade C / D
Classified areas
Classification and qualification of room and HVAC system. The test depth for individual room functions follows the risk assessment.
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CNC
Controlled not classified
Tested where the risk assessment shows an impact on the product, for example temperature in a store. Otherwise technical acceptance and complete documentation are sufficient.
Running projects
Your project is already under way? We join where you are.
In practice, design, construction and qualification run in parallel. We check the current status against your SOPs and GMP requirements and look at how the facility is actually used. Documents and reality do not always match.
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Review
Design, BoQ, drawings, customer SOPs
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Comparison
Requirements against GMP expectations
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Walk-through
Documents against actual use
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Findings list
met, conflict, not evidenced
Sample documents
What our documents look like.
Unique IDs, acceptance criteria before testing, approval fields and consistent references. All examples are fictitious samples.
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URS – requirements matrix 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.
Industries
For companies where evidence matters.
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Pharma
Medicinal product manufacturers with cleanrooms, HVAC systems, pharmaceutical water and process equipment.
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Medical devices
Medical device manufacturers with controlled production environments.
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GMP laboratories
QC and testing laboratories in GMP-regulated environments.
Projects
Typical assignments, without names.
For reasons of confidentiality we do not name clients. The project types show what we are regularly commissioned to do.
Project type 01 anonymised
GMP documentation for a new build
New GMP-relevant building section with cleanroom areas, HVAC and utilities. Several trades, each supplier with its own documentation status.
- QMP
- Risk assessment
- URS
- Traceability
Project type 02 anonymised
Qualification of a cleanroom area
Newly built cleanroom area that had to be qualified before production started.
- Cleanroom
- Room book
- DQ
- IQ
- OQ
- PQ
Project type 03 anonymised
Annex 1 gap analysis
Existing manufacturing areas were to be assessed against the requirements of the revised EU GMP Annex 1.
- Annex 1
- Gap analysis
- CCS
Project type 04 anonymised
Extension of compressed air and HVAC systems
Extension of existing compressed air and ventilation systems affecting GMP-relevant areas.
- Compressed air
- HVAC
- Change control
Insights
Articles from practice.
On master plans, risk assessment and URS, on DQ to PQ, room books, Annex 1 and audit preparation.
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
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
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
Contact
Tell us briefly about your project.
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.