Inspection Readiness

TMQA has provided the high level of quality oversight with Investigator as well as with clinical trial packagers under GMPs. TMQA’s flexibility, responsiveness and thoroughness in documentation has been instrumental to the success of the study. Perhaps most critical was the successful MHRA inspection of an Investigator after TMQA conducted a pre-inspection audit. We will continue using TMQA for our EU GCP needs.

QA Director, US based Pharmaceutical company

Preparing for a regulatory inspection

Preparing for and managing a regulatory or compliance inspection can be very time-consuming. Good, effective preparation will have a signification impact on the outcome of the inspection, so it is well worth taking the time and getting the help you need to get it right.

The TMQA Team helps many of our clients manage the preparation process for compliance inspections across all sectors, including GCP, GMP and GLP.

We can provide support throughout the complete inspection process including preparation, hosting and follow-up, or simply assist with the preparation in any area you feel needs attention. This can include conducting mock inspections and interview training.

Overview of the Inspection Readiness services we offer before inspections:

Mock Regulatory Inspections

  • Help to prepare for inspections
  • Advice on developing procedures for handling inspections
  • Guidance on the step-by-step process
  • Identify potential areas of risk (systems and procedures)

Mock Interviews

  • Help to prepare staff for compliance Inspectors’ questions
  • Provide feedback to staff on interview performance
  • Identify any remedial work required to be ready
  • Can apply to individuals or teams

Preparing sites for inspection

  • TMQA can also help you prepare your documentation and facilities for an inspection.

Help during an inspection:

Opening Meeting

  • Guidance and advice to help ensure you get your inspection off to a good start.

Regulatory Inspection Hosting

  • Advice on inspection do’s and don’ts to help you achieve an efficient and successful inspection.

Closing Meeting

  • Understanding and clarifying any issues raised by the Inspectors
  • Preparing constructive responses

Help after an inspection:

  • Review of inspectors’ findings
  • Identification of appropriate corrective actions and preventive actions
  • Preparing responses for regulatory authorities and clarifying any issues raised by the Inspectors