GAP analyses

A need to perform a gap analyses can arise, when there are differences between the current documentation and the requirements for documentation and thus the underlying processes.


When doing the gap analyses, it provides the basis for variations that update the documentation, so that the product meets applicable legal requirements, guidelines etc.

The need for gap analyses can occur e.g. when a pharmaceutical company has not submitted variations in line with changed manufacturing methods / manufacturing site in due time, but can also occur as a result of an inspection or audit. As a result of the approval of the submitted variations, the product will thus meet the legal requirements when they have been approved by the authorities.

Another need for gap analyses could occurs when a pharmaceutical company has not submitted variations in line with changes in the Company Core Data Sheet, CCDS in due time or  as a result of a referral, and where you also want a review / update of the entire SmPC.

When doing gap analyses for the Common Technical Document (CTD) Module 3 dossier (CMC) it is briefly to identify differences between the authorized / registered documentation, compared with the release documentation for the finished product. Gap analyses include the active drug substance (s) / auxiliary products, intermediates and the finished product.

Gap analyses include differences in specifications at release and at storage, parameters, limits, methods and shelf life, including storage conditions. In addition, the production site(s), pharmaceutical development, manufacturing methods, batch size, analytical methods etc. can be included. They will generally include an update with respect to the current regulatory requirements, guidelines etc.

During the gap analyses it may also be relevant to include assessment of the degree of the individual differences which may pose a safety risk for the user of the product and classification of the individual variations in relation to the national agencies. Due to different points of view and differences in national regulatory requirements across the EU, the latter may give rise to discussions and negotiations with the production sites.

Gap analyses for SmPC and PIL is done to briefly identify differences between the approved Summary of Product Characteristics, SmPC, compared with e.g. CCDS, often with a special focus on the safety section. Such gap analyses form the basis of safety and uniformity of the SmPC and PIL. They also usually include update with respect to the current QRD template.


Over a period of time gap analyses contribute to maintaining the marketing strategy and thus help to prolong the time when the product is on the market.


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