Your Trusted Global Partner in Supplier Qualification
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Our Audit Services
At GMP Check, we provide a fully managed GxP Audit Service to ensure global compliance and qualification of your suppliers and partners. We take care of your entire audit plan or individual audits, ensuring efficiency, transparency, and regulatory compliance.
Worldwide Network of Certified, Experienced, and Multilingual Auditors
From audit planning to supplier coordination and execution, we handle it all with minimal demand on your team
Audit reports delivered within 30 days
Coverage across all critical areas of the pharmaceutical, biotech, and healthcare supply chain
Turnkey Audit Solution Model (Client Minimal Involvement) - Just by answering 3 simple questions, we handle the entire audit process end-to-end, from coordination to final CAPA approval.
Fast-Track Audit Services - We can coordinate last-minute audits and deliver reports in 5 business days upon request.
End-to-End Supplier Qualification Management - RA, scoring, supplier classification; annual audit plan & execution for critical suppliers and non-critical suppliers management.
Worldwide network of certified and experienced auditors
GMP Check in numbers
Yanet Flor is the Founder and Quality Director of GMP Check. She is also a Certified GxP Lead Auditor and a former Quality Manager with over 13 years of experience in GMP/GDP compliance. Since fully dedicating herself to auditing three years ago, she has conducted 60+ audits across 20+ countries on 4 continents.
She is an active ISPE member and serves on the Board of Directors at ISPE Argentina, contributing to advancing pharmaceutical quality standards. Additionally, she volunteers with PDA, supporting industry best practices worldwide. Fluent in Spanish, English, and Italian, leads GMP Check in delivering top-tier audit and compliance solutions.
"Our role is to ensure supplier quality so our clients can focus on their business. Auditors are not judges but part of the QMS, and through empathetic communication and collaboration with suppliers, we can build a stronger quality assurance system to ultimately protect patients´ safety."
Good Manufacturing Practices Audits
We conduct GMP audits tailored to a wide range of pharmaceutical and biopharmaceutical operations, ensuring compliance with international standards and best practices.
1. Medicinal Products
Audits for finished dosage forms assess compliance with key quality systems—production, quality control, and documentation—based on EudraLex Volume 4, Part I and 21 CFR Parts 210–211. We ensure products meet the highest standards of safety and efficacy. For sterile processes, guided by Annex 1, we focus on contamination control and personnel qualification.
2. Active Pharmaceutical Ingredients (APIs)
Our audits cover the entire API supply chain, from raw materials to final release, following ICH Q7. We evaluate contamination control, equipment qualification, and change management in both chemical and biotech APIs.
3. Raw Materials & Excipients
Audits follow IPEC guidelines, focusing on supplier qualification, traceability, and risk-based controls to ensure the integrity of materials impacting product quality and patient safety.
4. Biotech Products
We assess compliance with EudraLex Volume 4, Part II, with attention to aseptic handling, cell cultures, and viral safety, reflecting the complexity of biological manufacturing.
Advanced Therapy Medicinal Products (ATMPs)
Audits align with EU Vol. 4, Part IV and PIC/S Annex 2A, emphasizing traceability of starting materials, environmental control, and patient-specific batch documentation.Radiopharmaceuticals
We audit the handling of radioactive materials per EU Annex 3, focusing on containment, short shelf-life logistics, and operator safety.
5. Investigational Medicinal Products (IMPs)
Our audits follow EudraLex Annex 13, reviewing GMP compliance for clinical trial materials—covering blinding, randomization, and documentation to protect patient safety and ensure data reliability.
6.Other GMP-Regulated Activities
+39 379 173 3726
Via Pasquale Stanislao Mancini 25,
Rome, Italy
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