Tailored GXP Gap Assessments

Understanding that every organisation is different, we use our expert knowledge to evaluate your systems, processes and procedures against specific regulatory requirements to highlight gaps and propose solutions to meet and enhance regulatory compliance.

More detailed than an audit, the gap analysis encompasses a deep dive, end-to-end detailed holistic assessment of specific systems, processes, and procedures against current guidance and regulatory expectations, to identify any gaps and weaknesses and develop comprehensive compliance improvement plans.

Such assessments have been used by our clients as a valuable tool to identify compliance gaps, prioritise actions, enabling them to achieve or return to a state of compliance when undertaking a wide range of projects including:

Remediation support activities to address MHRA inspection deficiencies
Detailed assessments of facility design plans and the associated personnel and product flows for compliance with EU GMP
EU GMP Annex 1 sterility assurance control strategy
Assessing the adequacy of Pharmaceutical Quality System activities e.g. Senior Management Quality Reviews, Supplier approval process, Validation Master Plans
Systematic review of clinical trial sponsor systems for maintaining oversight of outsourced activities
Establishing the required elements for a standalone PV system to meet the needs of a new UK entity following company merger

Why Choose EPiC for your GXP Gap Assessment?

Benefit from our expert knowledge, understanding, and interpretation of EU GXP regulatory requirements derived from extensive real-world industry and regulatory experience to identify and address compliance gaps that could have a negative impact on patients and business success.

Next Steps

Contact us today to learn more about how our GXP Gap Assessments can help maximise your compliance improvements by providing a roadmap for success.