Keane Analytical Ltd    Consultant Chemical Analysts

Keane Analytical is GMP compliant and maintains high quality standards at all times

All analytical work is conducted in accordance with Good Manufacturing Practice (GMP) principles and guidelines as given by Directive 2003/94/EC. This is confirmed by regular inspections by the Medicines and Healthcare products Regulatory Agency (MHRA), the last of which was carried out in February 2013. Keane Analytical passed this audit with no major non-compliances or the need for any significant corrective actions. In addition to inspections by the MHRA, Keane Analytical is subject to frequent customer audits, and again, they have always satisfied these requirements.


    

All activities at Keane Analytical are controlled by written procedures, including SOPs and policies. All instruments have SOPs for their use and calibration/performance qualification and all have a fully documented history. Each customer is allocated their own specific laboratory note book. Procedures are in place such that full traceability of a customer sample is possible from receipt through to the production of the certificate of analysis. All results are peer reviewed before confirmation of the result to the customer.
 

Download a copy of our MHRA Certificate by clicking the PDF icon

 

Whatever your product, let Keane Analytical be responsible for the quality of your analysis. Our clients can be assured of an excellent service.






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• Passed MHRA audit in September 2010
• All equipment qualified/calibrated
• Each customer has own designated lab books / files ensuring confidentiality & availability of data
• Cross-validations with customer carried out at beginning of project
• Customer audits welcomed