The strategic importance of regulatory inspections in the pharmaceutical industry

Regulatory inspections by competent authorities are vital components of ensuring compliance and quality in the pharmaceutical industry.

GCP Regulatory inspections are completed to ensure the protection of the rights, safety, and welfare of human research subjects involved in regulated clinical studies; to verify the accuracy and reliability of study data submitted to the competent authorities in support of research or new drug product applications; and to assess compliance with statutory requirements and regulations.

The cornerstone of inspection readiness lies in ongoing Sponsor oversight activities from the outset of a clinical trial.

A structured risk management framework is needed to ensure consistent output and handling of risks/issues that may impact inspection success and drug approval.

The Sponsor should define the critical data and processes associated with a specific study in a risk management plan. Risk management activities include but are not limited to the review and approval of study-specific plans, the establishment of a risk-appropriate monitoring strategy, and the completion of audits to identify any potential compliance gaps and foster a culture of continuous inspection readiness throughout the study and organization.

Any quality issues and/or risks identified during the trial should be thoroughly investigated and remediated. Additional training, more frequent monitoring visits, etc. should be put in place to increase awareness and ownership of quality issues and risk management.

Mock inspections can also be an invaluable tool.

Conducting simulated inspections replicates the intensity and scrutiny of an inspection, allowing teams to identify areas for improvement and refine their responses in an accurate setting.

Practicing presentations on anticipated topics and developing storyboards/narratives for potential questions help Subject Matter Experts (SMEs) convey complex information thoroughly, succinctly, and confidently.

Feedback from mock inspections provides insights that can be incorporated into final preparations/ ongoing inspection readiness activities.

Inspection readiness may feel overwhelming while study team members are concurrently running other trials at the same time.

However, the workload is more manageable if an inspection readiness mindset and activities are implemented from the start of a program/study.

Study team members must keep in mind that inspection readiness is not just a box to check, it is a strategic imperative for pharmaceutical organizations aiming for success in a highly regulated environment.

Veronique Brisson is G&L’s Assistant Vice President of Quality Assurance.