Perform GAP Assessments

GMP Consultants routinely conduct GAP Assessments for clients. They can be general GMP Assessments to ensure that the company meets regulatory GMP requirements or they can be specific assessments, on topics such as Data Integrity, Cleaning Validation, QMS, Analytical Services, New Regulatory Guidance, etc.

Our GAP Assessment reports will provide you with a detailed analysis and comparison of your current processes / procedures to the regulatory guidance and standards. Any GAPs identified will be assigned a severity risk, according to the possible effect on the product quality and regulatory compliance.

This helps your company prioritize changes to get the most effective output.

We will also include in the GAP Assessment report, recommended corrective actions.

GMP Consultants can provide corrective action support, progress tracking, on-site training and guidance, as well as GMP Inspection support.