Welcome to GxP Quality Systems ®

To develop knowledge and ethical thinking in your workforce and ensure they are competent and committed to implementing your quality management or GxP systems.

To ensure continuous compliance and improvement of your facility and quality systems and those at your outsourced activity providers (contract manufacture, testing and distribution).

Auditing is available to establish the current levels of regulatory compliance at your company and throughout your entire supply chain.

 

Revised EU GMP Chapter 8 Complaints, Quality Defects & Recalls  -  effective March 2015

Are you confident that your quality management systems has addressed the extensive new requirements and is compliant and  inspection ready?

  1. Complaint Data Management - are you confident that you are capturing, risk assessing and trending all complaints and quality defects?
  2. Quality Risk Management – have you incorporated Quality Risk Management principles into the following elements of your complaint handling system?
    • quality defects and complaint investigation
    • product recalls
    • other risk mitigation actions

        3. Root Cause & CAPA - do you have effective root cause analysis  and CAPA systems in place and do your staff know how to use them?

GxP Compliance Gap Analysis

We can conduct a gap analysis as a first step towards ensuring you are compliant.

 

 

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Services

GxP Quality Systems offers a range of Training, Auditing and Consultancy services in Quality Systems and GxP systems such as GMP/cGMP to the Pharmaceutical and Medical Device Sectors in Ireland and the UK.

Clients

GxP Quality Systems clients include manufacturers of Active Pharmaceutical Ingredients (APIs), Finished Pharmaceuticals, Biotech products, Medical Devices, Diagnostics, Cosmetics and Food Supplements.




HRPA
Food & Drug Administration -USA
Medicines & Health Care Products Regulatory Agency- UK
Pharmaceutical Inspectors Co-Operation Scheme
International Conference on Harmonization
EU Gxp Legislation at Eudralex
European Medicines Agency