GMP Audits & Compliance
We find the gaps before the inspector — and prepare your team for the inspection.
We prepare your operation for regulatory scrutiny: we find gaps before the inspector, qualify suppliers and train the team to run the inspection confidently.
Internal audits and gap assessments against GMP, with findings classified by criticality and an associated action plan (CAPA).
Qualification and audit of suppliers and providers, plus mock inspections that simulate the real dynamics of an inspection.
Deliverables cycle
Internal Audit Program
Scope, schedule and risk-based checklists for internal audits.
Supplier Audit
Qualification and assessment of critical third parties.
Mock Inspection
Inspection simulation with feedback and team preparation.
Findings Report & CAPA
Non-conformities prioritized with corrective and preventive action plans.
How we run it
Plan
Scope and risk-driven checklists.
Audit
On-site or remote execution.
Report
Findings by criticality and CAPA.
Prepare
Mock inspection and team coaching.
Applicable standards
Frequently asked questions
Do you do remote audits?
Yes, on-site or remote, depending on risk and supplier location.
What is a mock inspection?
A realistic simulation of a regulatory inspection to train the team and reveal weaknesses before the inspector.
Do you help with CAPA?
Yes. We structure and follow up corrective and preventive action plans.