Remote and Onsite GMP Gap Assessments and Audits

What the Assessment Covers

Our assessments cover documentation, processes, facilities, equipment, and personnel training. Whether conducted remotely or at your facility, we look at your operation the way an auditor or FDA investigator would, from receiving of ingredients to product out the door, and we look at the records the same way. Each assessment results in a detailed report with prioritized findings and clear corrective action steps.

• Full-scope facility and documentation review
• Prioritized findings with risk classification
• Root cause analysis for each identified gap
• Corrective action plan with realistic timelines

What Happens After the Report

A gap assessment is only useful if the gaps get closed. We do not hand over a report and disappear. Depending on what the assessment finds, we help you build missing systems through our process design and implementation work, close serious findings through a structured GMP remediation program, or get your team ready for the real thing with inspection readiness and mock audits. We serve cosmetics, dietary supplement, food, medical device, and pharmaceutical manufacturers, onsite across California and remotely nationwide.

Gap Assessment Questions

What is a GMP gap analysis or gap assessment?

A GMP gap analysis, also called a gap assessment, is an evaluation of your current manufacturing operations against FDA and industry GMP standards to identify compliance gaps. It covers documentation, processes, facilities, equipment, and personnel training, and results in a detailed report with prioritized findings and corrective action steps.

Can a gap assessment be done remotely?

Yes. Documentation-focused assessments work well remotely via live video and document sharing. A full assessment that includes walking the facility is most effective onsite. Many clients combine the two.

What do we get at the end?

A detailed report with prioritized findings, risk classification, root cause analysis, and a corrective action plan with realistic timelines. It is a working plan your team can execute, and we can stay on to help implement the corrections.