GMP & GDP Audit Services
Auditing is not a formality — it is your primary tool for verifying that quality systems work as intended. Our auditors bring 500+ audits of experience across manufacturers, distributors, suppliers, and logistics providers worldwide.
Wanneer dit de juiste keuze is
Organisations engage our audit services when they need:
Independent supplier or vendor qualification audits as part of their approved supplier programme
A mock inspection or self-inspection that replicates the rigour of a competent authority visit
A GxP gap assessment before a major regulatory submission, site change, or new product launch
Third-party audit capability because their internal team lacks capacity, specific expertise, or independence
Follow-up audits to verify that corrective actions from previous findings have been effectively implemented
Wat u krijgt
Every audit produces actionable intelligence — classified findings, root cause context, and clear expectations for corrective action.
Supplier & Vendor Audits
On-site or remote audits of your suppliers, contract manufacturers, laboratories, logistics providers, and other third parties. Conducted against EU GMP, GDP, or your custom quality agreement requirements.
Mock Inspections
A realistic simulation of a regulatory inspection at your own site. We follow the same methodology as competent authorities — opening meeting, facility walkthrough, document review, personnel interviews, and a formal closing with classified findings.
Gap Assessments
Systematic evaluation of your operations against a specific standard or guideline. Ideal for benchmarking compliance before a known inspection, licence application, or when adopting new regulatory requirements.
Audit Programme Design
If you need to build or restructure your internal audit programme, we design risk-based audit schedules, develop audit checklists, train your internal auditors, and establish CAPA tracking processes.
International Audits
Audits at supplier and manufacturing sites worldwide. Our auditors have conducted audits across Europe, Asia, and the Americas, and understand both the local regulatory landscape and the expectations of EU-based importing companies.
Hoe wij werken
We tailor each audit to its purpose. The scope, depth, and reporting format depend on what you need the audit to achieve.
2–5 days
One site, one clear outcome
Typische deliverables
- Pre-audit document review and risk-based audit plan
- On-site audit with classified findings (critical, major, minor)
- Formal audit report with CAPA expectations and response deadlines
Annual
Systematic supplier oversight
Typische deliverables
- Risk-based audit schedule covering your approved supplier list
- Coordinated audit execution across multiple sites and geographies
- Consolidated trend reporting and supplier risk dashboard
1–3 days
Test your inspection readiness
Typische deliverables
- Full simulation of a competent authority GMP or GDP inspection
- Classified findings report mirroring regulatory inspection format
- Debrief session with practical recommendations and priority actions
Typische doorlooptijd
Preparation
We begin with a pre-audit phase: reviewing relevant documentation, quality agreements, previous audit reports, and regulatory history. We develop a risk-based audit plan tailored to the site and scope. For supplier audits, we coordinate scheduling and logistics directly.
Audit Execution
On-site audits follow a structured methodology: opening meeting, facility tour, document and record review, personnel interviews, and a closing meeting with preliminary findings. Our auditors are experienced, direct, and thorough — you will know exactly where you stand before we leave the site.
Reporting & Follow-up
You receive a formal audit report with findings classified by severity, supporting evidence, and CAPA expectations with proposed response deadlines. For supplier audits, we can manage the CAPA follow-up process on your behalf, including verification of corrective action effectiveness.
Wat klanten ervaren
Voorbeeld (geanonimiseerd)
A multinational pharmaceutical company outsourced their annual supplier audit programme to PCS after their internal quality team could not keep pace with a growing approved supplier list. Over 12 months, we conducted 24 audits across 8 countries, identified 3 suppliers requiring immediate corrective action, and provided consolidated trend analysis that informed the company's supplier risk strategy.
Bekijk meer klanten en resultaten →"Their auditors found things our own team had missed for years. The reports were thorough but practical — our suppliers could actually act on the findings."
Veelgestelde vragen
Our auditors are senior quality professionals with extensive pharmaceutical industry experience. They hold relevant qualifications and have typically conducted hundreds of audits over careers spanning manufacturing, distribution, and quality assurance leadership roles. We match auditor expertise to the specific scope of each audit.
Yes. We regularly conduct audits in Asia (India, China, South Korea, Japan), the Americas, and the Middle East. Our auditors are experienced in navigating different regulatory environments and cultural contexts while maintaining consistent EU-standard audit rigour.
We use a three-tier classification: Critical (direct risk to product quality or patient safety, or data integrity breach), Major (significant departure from GMP/GDP that could lead to a critical situation), and Minor (departure from guidelines or best practice that does not directly impact product quality). This aligns with the classification used by most EU competent authorities.
A mock inspection simulates a real regulatory inspection — it tests your people, processes, and documentation under realistic pressure. A gap assessment is a systematic, checklist-driven evaluation against a specific standard. Both produce classified findings, but a mock inspection also evaluates your team's ability to respond to inspectors in real time.
Yes. We can manage the full cycle: risk-based scheduling, audit execution, reporting, CAPA follow-up, and annual trend analysis. Many organisations use this model to maintain a robust approved supplier programme without expanding their internal QA headcount.