How can you create a GMP inspection plan?

1 Define the purpose

The first step in creating a GMP inspection plan is to define the purpose of the inspection. Why are you conducting the inspection? What are the expected outcomes? Who are the stakeholders? The purpose of the inspection should be clear, specific, and aligned with your GMP objectives and policies. The purpose of the inspection should also determine the type and frequency of the inspection, such as routine, for-cause, pre-approval, or follow-up.

2 Identify the scope

The second step in creating a GMP inspection plan is to identify the scope of the inspection. What are the areas, processes, systems, or products that you want to inspect? How deep and broad do you want to go? The scope of the inspection should be based on a risk assessment, which considers the potential impact, likelihood, and severity of any non-compliance or deviation. The scope of the inspection should also be realistic, feasible, and manageable, given the available resources and time.

3 Establish the criteria

The third step in creating a GMP inspection plan is to establish the criteria for the inspection. What are the standards, regulations, guidelines, or best practices that you want to measure against? The criteria for the inspection should be relevant, valid, and up-to-date, reflecting the current GMP requirements and expectations. The criteria for the inspection should also be consistent, transparent, and documented, ensuring that the inspection is objective and fair.

4 Select the methods

The fourth step in creating a GMP inspection plan is to select the methods for the inspection. How will you collect, analyze, and report the inspection data? The methods for the inspection should be appropriate, reliable, and effective, enabling you to obtain accurate and sufficient evidence of compliance or non-compliance. The methods for the inspection should also be flexible, adaptable, and collaborative, allowing you to adjust to changing circumstances and involve relevant parties.

5 Assign the roles

The fifth step in creating a GMP inspection plan is to assign the roles for the inspection. Who will be responsible for planning, conducting, and reporting the inspection? The roles for the inspection should be defined, qualified, and trained, ensuring that the inspection team has the necessary skills, knowledge, and experience. The roles for the inspection should also be independent, impartial, and accountable, ensuring that the inspection team has no conflict of interest or bias.

6 Prepare the schedule

The sixth and final step in creating a GMP inspection plan is to prepare the schedule for the inspection. When will you conduct the inspection? How long will it take? The schedule for the inspection should be realistic, achievable, and agreed, ensuring that the inspection is completed within the expected timeframe and budget. The schedule for the inspection should also be communicated, coordinated, and confirmed, ensuring that the inspection is well-organized and supported by all stakeholders.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?