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

Here are some Frequently asked questions and answers around EPiC’s GxP GAP Assessment services:

What is a GxP gap assessment?

A gap assessment is a diagnostic review of your quality systems, processes, and documentation to identify areas that fall short of current regulatory expectations or best practices.

How is a gap assessment different from an audit?

Unlike audits, which focus on compliance verification, gap assessments are more collaborative and improvement focused. They involve a detailed review of specified systems, processes, and procedures against current GXP guidance and regulatory expectations to identify gaps and weaknesses. They help you proactively identify and fix issues before they become regulatory risks.

Who should consider a gap assessment?

Any company preparing for a regulatory inspection, launching a new product, or undergoing organisational change should consider a gap assessment to ensure systems are practicable and capable of meeting both operational needs and regulatory requirements.

What areas are typically reviewed?

We assess GXP quality management systems, specific manufacturing processes and systems, approaches to data governance, Sponsor strategies for oversight of clinical trial activities and more, tailored to your specific GxP scope.

Yes. We don’t just identify gaps—we help you close them. Our team can support SOP development, training, and system redesign to ensure sustainable compliance.

Can EPiC help implement changes after the assessment?

Is the assessment tailored to our regulatory region (e.g., MHRA, FDA)?

Absolutely. We customise each assessment based on your market, product type, site activities and applicable regulatory frameworks, including MHRA, EMA, FDA, and PIC/S.

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.