GMP Audits

A GMP audit is the single most reliable way to know whether a manufacturing site will withstand a regulatory inspection — and whether the product it ships is fit for your market. PharmExpert performs Good Manufacturing Practice audits across the full manufacturing spectrum: active pharmaceutical ingredients and intermediates, sterile and non-sterile finished dosage forms, biologics, and contract manufacturing organizations. Whether you are qualifying a new supplier, conducting periodic oversight, or stress-testing a site before an agency arrives, the audit gives you an objective, evidence-based picture of compliance risk.

Our lead auditors assess the site against the framework that matters for your supply chain — EU GMP Parts I and II, US FDA 21 CFR Parts 210/211, ICH Q7 for APIs, WHO TRS guidance and PIC/S. We examine the pharmaceutical quality system end to end: premises and utilities, equipment qualification and process validation, materials management and production controls, the quality-control laboratory, documentation and data integrity, and the maturity of the site's own self-inspection and CAPA culture. Nothing material is taken on trust; findings are grounded in records, observation and interview.

What distinguishes a PharmExpert audit is genuine independence. Because we manufacture nothing and sell no products, there is no commercial incentive to soften a finding or inflate a concern — you receive a candid assessment calibrated to real risk. Every observation is risk-ranked as critical, major or minor, tied to a specific regulatory clause, and accompanied by remediation direction your team can act on, so the report is a tool for decisions rather than a list of complaints.

We scale the engagement to your need and timeline. A single urgent supplier audit, a routine periodic audit, or a global qualification program across dozens of sites are all delivered through the same standardized audit life-cycle and harmonized report templates, with remote and hybrid options where travel or access constrain you. Every audit is recorded in our verifiable audit-report database, enabling shared audits that cut cost and audit fatigue across sponsors who rely on the same suppliers.