GMP Audit Services
Independent audits of your facility, systems and suppliers, scoped and signed off by the Amicus principal who owns the engagement.
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Identify your highest-risk GMP gaps.
89 clients supported. 125+ years of combined GMP experience.
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
GMP Audit Services for Regulated Life Science Companies
An audit is only worth what you do with the findings. Too many arrive as a long report, ranked by the order the auditor happened to look at things, with no view on what to fix first or how long it will take.
Every Amicus audit is scoped by a principal who has sat on both sides of an inspection, and the same principal reviews and signs off on the findings before you see them. The fieldwork may be carried out by a senior consultant working to that plan. What you receive is the same whether you make APIs, biologics or compounded sterile products: findings ranked by risk, a remediation sequence you can resource, and a written report you can hand to management without rewriting it. Where you want help closing the gaps, the same team stays with the work.
Jamie Duncan, CQAPrincipal, QualityJamie brings nearly a decade of experience in pharmaceutical quality, compliance and operations within highly regulated environments. She holds ASQ Certified Quality Auditor and Certified Manager of Quality/Organizational Excellence certifications, plus a Lean Six Sigma Green Belt.
- Quality system development and optimization
- Internal audits and compliance readiness
- Process improvement and operational excellence
Becca Mitchell, PharmDPrincipal, Quality & RegulatoryOur GMP Audit Services
Internal GMP Audits
A structured review of your facility, quality systems and documentation against 21 CFR Parts 210 and 211 and current FDA expectations. Conducted onsite or remotely, scaled to your operation rather than run from a generic checklist.
Supplier Audits
Your suppliers are part of your quality system, and FDA treats them that way. We audit and qualify suppliers of APIs, excipients, components and services, and help you build the ongoing oversight that keeps qualification meaningful after the first visit.
CDMO Audits
Contract manufacturing introduces distance between you and the process. We audit CDMO operations against your quality agreement and your regulatory obligations, and give you a clear view of where your oversight has gaps rather than where their paperwork does.
Mock FDA-Style Inspections
A full mock FDA-style inspection, run at the pace and pressure of the real thing, whether you are expecting routine surveillance or a pre-approval inspection (PAI). Our consultants play the investigator role, asking the same probing questions and requesting the same records, so your team practices staying accurate and consistent under scrutiny before it counts.
Pre-Approval Inspection (PAI) Readiness Audits
A PAI examines whether the data in your application matches what happens on the floor. We audit the batch records, method validation, stability data and process controls behind the submission, trace the application back to source records the way an investigator will, and give you a ranked list of what to close before the agency schedules the visit.
Audit Findings and Remediation Support
Findings ranked by risk, a prioritized remediation sequence, and hands-on support to close them. We do not stop at telling you what is wrong.
Common GMP Audit Challenges We Help Solve
Gaps in Quality Systems
Deviations that close without effectiveness checks, a CAPA backlog that keeps growing, change control that gets bypassed under schedule pressure. These are the findings that repeat, because the audit fixed the instance and not the system.
Supplier and Partner Oversight Risks
Qualification completed once and never revisited, quality agreements that do not reflect what actually happens, and limited visibility into a CDMO’s own quality system.
Inconsistent Documentation and Records
Batch records that contradict each other, missing supporting evidence, and training files that cannot demonstrate competence. Investigators build findings from records, so this is where audits should look hardest.
Readiness for Surveillance and Pre-Approval Inspections
Knowing your systems are compliant is not the same as being able to demonstrate it under questioning. An audit tells you the first. A mock inspection tells you the second. Before a PAI the bar is higher still: the agency will check that your application data, your records and your floor all tell the same story, and a readiness audit is how you find out whether they do.
Why Companies Choose Amicus for GMP Audit Services
A named Amicus principal owns every audit. The principal scopes the work, defines what the audit will look at and why, and reviews and confirms every finding before the report reaches you. Senior consultants may carry out the fieldwork, working to that plan, and the same team stays to help you close the findings if you want it. With 125+ years of combined GMP experience across 89 clients, our principals have audited operations at every stage from first registration to routine surveillance.
What Our Clients Say
Our mock FDA audit with Amicus was incredibly helpful. They clearly explained where we had gaps, prioritized the issues, and offered practical ideas for fixing them. It gave our team much more confidence going into future inspections.
Director of Quality503B Outsourcing Facility
Working with Amicus on a mock FDA audit was a great experience. Their team was thorough, professional, and easy to work with, and they provided clear feedback that helped us better understand regulatory expectations.
Pharmacist in Charge503B Outsourcing Facility
Frequently Asked Questions
Most facility audits run one to three days onsite, depending on the scope and the size of the operation. We agree the scope and duration with you before we start, and we tell you if we think the scope is too narrow to be useful.
A principal scopes it and signs off on the findings. Depending on the scope, the principal or a senior Amicus consultant carries out the fieldwork. Either way, the report you receive has been reviewed and confirmed by the principal who owns the engagement.
Quality leadership throughout, and subject matter experts for the areas in scope. We give you the document request list in advance so nobody is scrambling on the day.
A written report with findings ranked by risk, a prioritized remediation sequence, and a debrief with your team. The report is written to be handed to management as it is.
Yes. Many clients bring us in for the audit and keep us through remediation. Others take the report and run it internally. Both are fine, and we will tell you honestly which we think fits your situation.
Yes, both. Supplier and CDMO audits are a significant part of the work, particularly for teams whose manufacturing sits outside their own walls.
Related Compliance and Audit Services
FDA Inspection Readiness Consulting
Mock inspections, gap assessments and live inspection support.
FDA 483 & Warning Letter Response
Risk-ranked remediation when observations have already been issued.
Regulatory Compliance Consulting
Strategy, gap assessments and documentation support across FDA requirements.
Speak With a GMP Audit Consultant
Tell us what you are preparing for and we will scope an audit that answers it. If an audit is not what you need, we will say so.