What are the Strategies to a Proper Inspection Readiness

Pharma Tech Outlook: Pharma Tech Magazine

What are the Strategies to a Proper Inspection Readiness

Pharma Tech Outlook | Tuesday, July 21, 2020

The organizations must take a strategic approach for inspection readiness so that they can take their company to a better position to refine the necessary skills. IR activities are an important part of the organization to get through the inspection.

FREMONT, CA: As a sponsor, one of the most stressful jobs is health authority inspections, as preparing for an examination is never a care-free process. While taking a strategic and the right approach to the inspection readiness (IR) preparation, some of the pressure can be reduced by providing the team and programs with proper tools that can help them with navigating the inspection. Here are some of the best practices that can help an organization to become ready for review.

1. Timing is everything

The activities for IR must be a carefully planned and executed procedure based on the needs of the organizations. It is essential to give plenty of time to prepare for the inspection. However, the time for preparation can be made based on the size of your organization, the development stage, and the submission goals. For example, a large company has to start its planning from two to three years in advance. On the other hand, a smaller company can begin preparing for 12 to 18 months before submission.

2. Understand the current state of inspection readiness

The organization must have an estimation of its IR activities, and it is critical to complete it. The company can take the opportunity to learn and determine the current status of their organization regarding IP. The study team can tell the areas where there are high-risks or the issues that have occurred in the study. The organization must utilize the time to review audit reports and CAPAs (corrective and preventive actions) to make sure that any identified issues are adequately resolved.

3. Use the readiness assessment to think about what activities to prioritize

The information that is collected during the organizational readiness assessment must drive the IR activities. For the people to stay engaged and immersed during inspection readiness activities, it is essential to have a better understanding of the things that can bring value. Organizations have to be transparent and explain to the teams about the reasons for the activities that are performed, so they also stay motivated and feel utilized.

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