Mobile cGMP Development, Testing and Qualification
Dublin, Ireland
cGMP Development, Testing and Qualification. Simplified.
Mylab.ie offers mobile cGMP certified testing laboratories to save time and money on Development and Testing associated with cGMP Facility, Utility, Cleaning and Sterilization Validation activities.
Mylab.ie is taking bookings now with full cGMP certified launch in Q1 2018
Services Offered
Our state of the art mobile laboratories comes to your site and we supply all equipment and personnel to quickly and compliantly perform development, testing and validation activities on your systems, including:
Environmental Monitoring
We can support your Performance Qualification effort by performing onsite QC testing to EU, JP or FDA standards for your Facility and Clean Utility systems. We can create and execute protocols if required.
Cleaning Cycle Development
Our mobile laboratory has the capability to develop full cGMP Cleaning Validation strategies which will increase regulatory compliance and decrease validation time and associated costs.
CIP and SIP
Validation
Once the development activities are complete and transferred to site we can process and test all Cleaning Validation and Sterilization Validation samples requiring QC testing in our cGMP mobile laboratory.
Benefits to You
Saves you Time
By offering site based laboratory testing we can decrease the time required to get facilities, equipment and utilities validated as your own testing laboratories may not be released for operation.
Saves You Money
Our service model is able to offer 25-50% saving compared to traditional outsourced development and testing. You do not need to invest in laboratories or personnel to support qualification.
cGMP Compliant
We are undergoing accreditation as a cGMP testing laboratory by the Health Products Regulatory Authority (HPRA) of Ireland. We are also undergoing ISO 9001 certification.
Industry Expertise
All our leadership team and staff have substantial pharmaceutical and biopharmaceutical gained in large HPRA and FDA regulated sites. We specialize in Clean Utility, Facility and Cleaning Validation.
State of the Art
Our mobile labs are designed and operated to cleanroom standards and we use the latest equipment technology available to ensure quick, safe and compliant development and testing to support your cGMP needs.
Secure and Cloud Based
Our Quality Management Systems is cloud based with a high level of encryption to ensure your data is safe. You will receive an individual login so that your data and reports are instantly available to you.
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