Good Laboratory Practice

Our GLP team has the experience and capability to conduct audits of all types including: facilities; process data; study specific data and reports against GLP requirements. We audit central laboratories and bio-analytical laboratories for routine and specialised analyses against both GLP and GCP regulations.

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Central laboratory audits

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GLP laboratory audits

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Advice on GLP accreditation

Find out how ADAMAS Consulting can help with your next project

Recent examples of our work:

Remote facility qualification of a full-service GLP laboratory.

Consulting for a GLP laboratory starting analysis of clinical samples.

Training and consulting for GLP accreditation.

The services we can provide include:

  • GLP audits of facilities, studies and reports
  • Assessment of laboratories for compliance with GLP regulations
  • GCLP audits of central laboratories handling human samples only
  • Audits of bioanalytical laboratory facilities to GLP and GCLP
  • Training of clinical staff in the requirements of GLP and GCLP

You will be pleased to hear that the lab has a very positive attitude to the report and are viewing it as a helpful guideline on how they can improve their processes.

F.M.

Project Manager, Global Pharma Company

Contact Us

If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.

Contact Adamas
The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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