GxP Auditing Services

TMQA are a highly professional and experienced auditing company, with subject matter experts across the GxPs. I have been very impressed with the level of service they have offered our company and am very happy with the quality of the work performed by all the auditors.

Associate QA Director (UK), Global Pharma Company

Here at TMQA we aim to provide a “one-stop shop” auditing service by conducting worldwide audits across all the GxPs. Our QA professionals are subject matter experts in their fields and have conducted audits for commercial and non-commercial organisations in over 40 countries across 5 continents.

The audit services we provide range from one-off individual audits through to complete global QA programmes. Examples of some of the services we have delivered for clients include:

  • Delivering complete QA programmes
  • Conducting individual in-life, data, report and vendor audits
  • QA oversight of studies in Europe for non-European sponsors

TMQA approach

Our approach to providing audit services is coherent and transparent. Our preference is to work on a fixed fee basis with the fee being agreed up front so there are no hidden budgetary surprises. Our projects follow a tried and tested process:

  1. Define the precise requirements for each audit
  2. Perform the audit ensuring the content and conduct are consistent with the client’s requirements
  3. Communicate continuously to ensure the client is aware of audit progress
  4. Report the audit promptly, clearly and concisely
  5. Support the follow-up and resolution of findings

Good Practice standards (GxP)

TMQA provides auditing services across all the GxPs:

  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)
  • Good Pharmacovigilance Practice (GVP)

Additional expertise

  • Medical devices
  • ISO standards
  • Academic, charity and other non-commercial research