Gap Analysis for Regulatory Compliance : Pharmaguideline

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Gap Analysis for Regulatory Compliance

Gap analysis is an effective tool to determine the deficiencies in implementation of any procedure or regulatory guidance.
If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis.

Gap analysis should be done for all SOPs, validation procedures and other activities to find out the possibilities of improvement. The room for improvement is identified by gap analysis. Therefore, make the checklists of the document you want to analyze and then check the actual working against the checklist.

Gap analysis in pharmaceuticalsGap analysis should also be done for regulatory guidelines like data integrity, risk assessment, good manufacturing practices, good laboratory practices, good documentation practices, good distribution practices etc to eliminate the possible non-compliances.

Gap analysis may be carried out for specific inspection like FDA, MHRA, WHO GMP, TGA, MCC etc. on the basis of respective regulatory guidelines.

Gap analysis is done step by step starting from purchase to final product dispatch. Gap analysis should be done in all departments in the following steps.

1. Identification of Areas
Check the list of the documents of the respective department and identify the areas to be analyzed for gap, according to the criticality of the process or system. Create a list of identified areas including SOPs, protocols and systems.

2. Preparation of Checklist
Create a checklist of checkpoints of the identified area by reviewing the related documents. Include each major or critical step in the checklist that should be followed during work. Format for the checklist is attached herewith.

3. Gap Analysis
Take the checklist that we had created in the previous step and check the actual working on the floor. For this analysis, you have to go to the area where the process is actually followed. Ask the personnel working in the area for the process they are following with respect to that particular checkpoint and note down the procedure.

4. Identification of Gaps
After analyzing the current processes, compare these with the regulatory guidance or the standard documents of the facility. Record the difference or gap between both in the checklist.

Also identify the severity of risk due to the gap, according to the possible effect on the product quality. Mark the risk as high, medium or low.

5. Corrective Action
Write the possible corrective action for each identified gap according to the standard document. Issue a copy of this checklist to the respective department for implementation of suggested corrective action with a deadline of maximum 30 days. To make the implementation more convenient you can give deadline according to the severity of the gap as 7 days for high risk, 15 days for medium risk and 30 days for low risk.

6. Review of Implementation
After the deadline, review the implementation of the corrective action suggested for filling the gap and record the status in the checklist.

Gap analysis is a solution before the occurrence of the problem. It is very helpful when carried out before any regulatory audit and works as a safeguard for non-compliance.

Format for Checklist:
Gap Analysis
Regulatory/ Standard Guidance
Current Practice
of Risk
Action Taken
(After 1 month)

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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