How do you conduct a GMP document gap analysis?

1 Define the scope

The first step is to define the scope of your document gap analysis. This means determining which documents and records you need to review, which GMP standards and regulations you need to comply with, and which areas or functions of your organization are involved. You can use a matrix or a checklist to map out the scope and prioritize the most critical or high-risk documents and records.

2 Gather the documents and records

The next step is to gather all the documents and records that fall within the scope of your document gap analysis. This may include policies, procedures, work instructions, forms, templates, reports, logs, certificates, labels, and any other evidence of your activities and outputs. You should ensure that you have access to the most current and approved versions of the documents and records, and that they are organized and labeled clearly.

3 Review the documents and records

The third step is to review the documents and records against the GMP standards and regulations that apply to your organization. You should check for any gaps, errors, inconsistencies, ambiguities, or redundancies in your documentation and records. You should also evaluate the effectiveness, efficiency, and usability of your documents and records. You can use a rating system or a scoring method to measure the level of compliance and performance of your documents and records.

4 Identify the gaps and root causes

The fourth step is to identify the gaps and root causes of any issues or problems that you found in your document review. You should document the gaps and root causes clearly and objectively, and categorize them according to their impact, frequency, and severity. You should also analyze the root causes of the gaps and determine the underlying factors or reasons that led to them. You can use tools such as the 5 Whys or the fishbone diagram to facilitate your root cause analysis.

5 Develop an action plan

The fifth step is to develop an action plan to address the gaps and root causes that you identified in your document gap analysis. Your action plan should include the following elements: the gap description, the root cause analysis, the corrective or preventive action, the responsible person or team, the target date, the resources required, the expected outcome, and the verification method. You should also prioritize your actions based on their urgency, importance, and feasibility.

6 Implement and monitor the action plan

The final step is to implement and monitor your action plan to ensure that the gaps are closed and the root causes are eliminated or minimized. You should follow the steps and timelines of your action plan, and communicate with the relevant stakeholders throughout the process. You should also monitor the progress and results of your actions, and verify that they are effective and sustainable. You should document and record your actions and outcomes, and update your documents and records accordingly.

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?