After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit.
You can base your selection on the criteria established by the FDA and on the type of work your company does; for example, a good option would be a crucial Phase 3 study that was recently completed and includes a good number of subjects, and it is also important to consider the accessibility of the data and the staff that will participate in a specific study.
First, choose a location and a study, and later develop a plan for your mock audit based on your SOPs and on the right FDA compliance program manual.
This plan should clearly state:
Verdana;mso-bidi-font-family:Verdana">- The audit’s goals
Verdana;mso-bidi-font-family:Verdana">- The project and location you chose
Verdana;mso-bidi-font-family:Verdana">- The participants
Verdana;mso-bidi-font-family:Verdana">- The time frames for completing the audit
Be very diligent when addressing the requests for information that the mock inspector will issue, taking into account the significant questions about regulatory knowledge, data validation, observance of SOPs, and compliance documentation.
Even more so, include an educational program into the mock audit process. Define how and when the participants will be “debriefed”, and how you will follow up on the lessons learned from the exercise.
Once you start the mock audit, make it as real as possible. Follow a clear plan and treat the mock inspector exactly as you would treat the real one. Everyone must remain “in character” throughout the whole process to get the best out of the activity.
It can be educational to invite managers, executives, and members of other projects to observe the mock audit; and it is because of the educational aspect that the mock audit requires immediate and thorough review of the lessons learned after it is finished.
The review process has to include:
Verdana;mso-bidi-font-family:Verdana">- Comments from the mock inspector in regards to what was done well and what needs improvement.
Verdana;mso-bidi-font-family:Verdana">- Observations from the QA team and others who witnessed the activity.
Verdana;mso-bidi-font-family:Verdana">- Input from the participants about what happened during the audit and about the value of the activity.
Verdana;mso-bidi-font-family:Verdana">- The creation of an action plan to take care of compliance issues and organizational deficiencies that surfaced during the exercise.
Verdana;mso-bidi-font-family:Verdana">- A follow-up report to make sure the action plan is put into practice.
Take advantage of the debriefing process to ask the participants about any negative feelings that came up during the mock audit. A mock inspection may upset people, make them feel they were treated unfairly or criticized, or that the issues uncovered could be held against them.
Managers and executives who participated must make sure everyone understands that the results will not affect anyone’s job; otherwise, future mock audits will lose effectiveness due to employee fear.
Mock audits must be a regular practice of any pharmaceutical company’s training program; thus, it requires full management support and staff participation.
Pharmaceutical consultants believe that when these exercises are held at regular intervals, more and more people share the learning experience, and the company can regularly improve its level to face real audits as well as its operational systems.
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Nigel Smart is a pharmaceutical consultant and founder of the pharmaceutical consulting blog.