GAP or Findings in Regulatory Compliance
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 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 specifi