GAP Analysis

GAP Analysis is a process that compares actual performance or results with expected or desired. The method provides a way to identify strategies, structures, capabilities, processes, practices, technologies, or non-optimal or missing skills, and then recommends steps that will help the company achieve its goals.

By comparing the current state with the target state, companies, business units or groups can determine what they need to increase productivity or results, and move faster on the right track.

The GAP analysis provides the basis for measuring the time, money and human resources necessary to achieve a specific result.

GAP Analysis in the pharmaceutical industry:

GAP Analysis (also known as Validation GAP Analysis) in the pharmaceutical industry addresses the difference between regulatory requirements that affect the company and the practices and processes that the company is currently using.

  • What type of information?
  • Who will collect the information?
  • From where
  • How will the information be compared?
  • Where will it be stored?
  • Who will evaluate and analyze?
  • How will the information be distributed?
  • Who will distribute it?
GAP GAP Analysis Tool:
  • Phase 1: Identify Gaps
  • Phase 2: Fill Gaps

Make a list of requirements, usually in the form of questions Check whether the general description of all existing practices was written or not Otherwise, check for
  • 1. Adequacy
  • 2. Fitness
  • 3. Efficiency
  • 4. Compliance

Three answers are possible for each question:
Yes - Organization has met one of the requirements
No - Points to a gap
N/A - Question is not applicable to the situation
Each time NO response is received, there is a column to help the organization determine what processes need to be fixed

  • Quality management process
  • The internal Communications process.
  • Document Control Process
  • Office work
  • Training process
  • Internal audit process
  • Management review process
  • Measurement and monitoring process
  • Non-compliance management process
  • The process of continuous improvement

  • Gap analysis questions become action statements
  • These action statements formulate corrective actions that fill the gaps.
  • Develop gap management plans
  • These corrective actions are used to fill the gaps that are found
  • All corrective actions must be assigned a corrective action number.
  • Job responsibilities are issued to ensure that corrective actionscarried out

  • Identify performance gaps in relation to categories.
  • Identify gaps in related strategies and practices
  • Examine individual practices with low efficiency and high importance in categories and strategies with a large gap
  • Look for logical relationships and priority among practices
  • Develop an action plan and get a consensus on the plan.
  • The Gaps can be found in any process of organizational activities.GAP analysis is one of the best procedures to help lead an organization

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