A gap analysis is a tool used to determine the differences (gaps, also known as a delta) between an organization’s management system and the requirements of controlling criteria, such as standards or regulatory requirements. 


In pharmaceutical industry a gap exists where existing policies, processes or procedures do not fully meet the stated requirements.


A gap analysis checklist should be used to capture the gaps in your organization’s management system and the reference requirements, with the goal of determining: 

1. What existing company processes and procedures already meet the requirements; 

2. What existing procedures and processes need to be modified to meet yhe requirements; 

3. What additional procedures and processes need to be created to meet the requirements. 


Each pharma organization may  have in place a compliant quality management system (QMS) or you might be running an uncertified system; the gap analysis checklist provides a structured framework to help assess the current status of your QMS in terms of fulfilling the requirements. 


After the gap analysis, the organisation should have a clear picture of how existing quality management system compares with the requirements.


In general, the steps for conducting a gap analysis are: 

1. Reviewing what is the present operation/ process and what already exists; 

2. Analyzing the relevant sections of the Standard/ Guidelines/ requirements to determine what is actually required; 

3. Documenting the differences or gaps. 


These differences and gaps should be organized into a detailed findings list, for review and approval by top management.


In summary, the gap analysis in pharma industry should include a review of all processes and procedures for management controls and technical controls, such as for sampling, method validation, equipment calibration, qualification and maintenance, employee qualifications, and other


The knowledge obtained about the status your existing quality management system will be a key driver of the subsequent implementation approach. 


Using the output of the gap analysis, you can develop a findings list, which can include additional tasks such as selecting and dealing with an accreditation or certification body/ Regulatory Agencies.


Not only will a gap analysis help to identify the gaps, it will also allow to recommend how those gaps should be filled. 


Armed with this knowledge, it allows to establish accurate budgets, timelines and expectations which are proportional to the state of your current management system when directly compared to the requirements.


The gap analysis output, in the form of a findings list provides a valuable baseline for the implementation process as a whole, and for measuring progress. 


Resource Person: Barbara Pirola