GAP ANALYSIS TOOL

Working as a validation consultant, you quickly realize that one of the first things your client wants is the execution of a Gap Analysis (GA). A reassurance that all discrepancies have been identified and reconciled - in house. When a problem is missed and a visiting regulator discovers it, the issue can be, and very often is, damaging to individual careers and to the employing company. Execution of a GA gives tremendous reassurance that the ship is water tight and under command.

The GA tool allows you to systematically challenge the company’s cGMP policies and procedures, comparing them with the regulatory expected standards and enables you to draw up a list of all the delinquencies. Until you can highlight the company’s deficiencies, you are not able to scope the task of becoming compliant. It really is difficult and verging on the impossible to put resources together for an unmeasured task.

Recently the FDA has created and approved the Quality Systems (QS) guideline to impart a consistent set of requirements that will compliment the current cGMP’s and provide the tools for industry to implement effective QS’s that will guarantee the best product quality for the customers. The next step for most companies is to perform a GA to determine what actions are necessary for them to be in compliance with the new guideline. The GA must be conducted as a planned / organized process and must be documented. The personnel conducting the GA analysis must also be qualified and must prioritize the areas to be inspected. It must be verified that the cascade of documents used in qualifying equipment i.e. VMP - VP - URS - DQ - IQ - OQ - P1Q - P2Q, is in place and has been constructed in accordance with the company's practices and procedures manual.

This goal of the GA in the pharmaceutical industries is to identify the gap between the regulatory requirements governing the company operations and the practices and processes actually in use. This helps provide the company with insight into areas that have room for improvement. The GA process involves determining, documenting and approving the variance between requirements and current capabilities. Once the general expectation of performance in the industry is understood it is possible to compare that expectation with the level of performance at which the company currently functions. This comparison becomes the gap analysis. Such analysis can be performed at the strategic or operational level of an organization.