About X-Mon
Qualification and GMP documentation. Since 2013.
X-Mon Germany GmbH is an independent service provider for technical GMP projects. We qualify cleanrooms, HVAC systems, compressed air, pharmaceutical water and process equipment and produce the documentation that goes with it.
Company
Small by design, clear on responsibility.
X-Mon Germany GmbH was founded in 2013. Our clients are manufacturers of medicinal products and medical devices and GMP-regulated laboratories. For their technical systems they mainly need three things: qualification that stands up to an inspection, documents that fit together, and an honest assessment of where they stand regulatorily.
We deliberately work as a small unit. Lines are short, responsibilities are clear, and whoever starts a project also finishes it. Where a measurement needs special equipment, we bring in experienced specialist measurement contractors as required. Responsibility for plan, assessment and report stays with us.
- Company
- X-Mon Germany GmbH
- Founded
- 2013
- Location
- Leonberg, Baden-Württemberg, Germany
- Register
- Stuttgart Local Court, HRB 745038
- Region
- Germany, Austria, Switzerland
- Industries
- Pharma, Medical devices, GMP laboratories
- Services
- Qualification, GMP documentation, GMP consulting, calibration
How we work
What X-Mon stands for.
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One fixed contact
The person responsible for your project stays with it from the first conversation to approval. There is no handover to a team that does not know the background.
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Testable, not voluminous
Documents should stand up to critical questions. A thick binder on its own convinces nobody in an inspection.
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Risk-based
Test depth where product and patient are affected. What adds no insight, we leave out and say why.
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Independent
We do not sell equipment and are not tied to any manufacturer. The benchmark is your requirements and the regulations.
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Confidential
We do not name clients or projects publicly. We are happy to sign confidentiality agreements.
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On site and remote
Based in Leonberg. Walk-throughs and tests on site, document work and meetings remotely where that works better.
Focus
Technical infrastructure that affects the product.
In many operations, rooms, air, water and utilities have a direct bearing on product quality. That is exactly where our focus lies.
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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.
Regulations
What we work to.
Which requirements apply in a given case depends on the product, the market and your SOPs. These regulations come up in almost every project.
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Part I plus Annex 1 (sterile manufacture), Annex 11 (computerised systems) and Annex 15 (qualification and validation)
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cGMP for finished pharmaceuticals, plus 21 CFR Part 11 for electronic records
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Quality risk management as the basis for scope and depth of qualification
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ISO 14644
Cleanrooms: classification, monitoring, test methods
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Ph. Eur.
Monographs for Purified Water and Water for Injections
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ISO 8573-1
Purity classes for compressed air
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GAMP 5
Industry guide for computerised systems
- All regulations and links at the source
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.