GXP Audits: Your Road to Compliance & Integrity

Adhering to Good Practices (GXP) is more than a regulatory requirement; it is a cornerstone of trust, quality, and excellence. Our team of experts, specializing in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Pharmacovigilance (PV), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) audits, stands ready to equip your operations with the highest standards of compliance and integrity.

Comprehensive GXP Audit Services

We support your internal, corporate and supply chain audit programs, helping you meet your quality oversight obligations. All our audits are carefully planned and carried out, focusing on GXP compliance, risk management and process improvement. With decades of auditing experience our consultants bring unmatched expertise to your team.

Our audit services encompass:

Supply Chain Audits: we specialise in conducting thorough supply chain audits that cover every aspect of the product life cycle from starting material manufacturers, API manufacturers, excipient suppliers, packaging suppliers, clinical development, medicinal product manufacturers and contract manufacturers, EU importation and testing through to QP certification activities.
Due Diligence Audits: proving expertise to conduct suitability assessments of suppliers, service providers, or in relation to mergers and acquisition activities, these audits will rapidly identify potential issues and gaps in relation to current industry and regulatory standards.
‘For Cause’ Audits: targeted audits in response to an incident such as a recall, complaint or adverse regulatory inspection finding, providing expert guidance to implement mitigating actions and effective CAPA.
Corporate GXP Audits: providing expertise and resource to support corporate audit programmes covering the full range of site or corporate function operations, assessing their compliance with internationally recognised GXP standards.

Here are some Frequently asked questions and answers around EPiC’s Gxp Audit services:

What is a GxP audit?

A GxP audit is a structured review of your operations to assess compliance with Good Practices, such as GMP, GDP, GCP, GPvP, and GLP. It ensures your systems meet regulatory expectations and industry standards.

Why are GxP audits important for pharmaceutical companies?

Regular audits help maintain compliance, ensure product quality and patient safety, and prepare your organisation for regulatory inspections. They providing an independent assessment of the current level of compliance and support continuous improvement by providing actionable recommendations to address compliance gaps.

What types of audits does EPiC offer?

We offer internal audits, supplier audits, GMP and GDP PQS audits, GMP and GDP site audits, clinical site audits, and pharmacovigilance audits. Each audit is tailored to your business model and regulatory obligations.

What types of audits does EPiC offer?

Can EPiC audit international sites?

Yes. EPiC has global experience and can audit facilities across Europe, Asia, the Americas, and beyond. We understand regional regulatory nuances and global compliance expectations.

How often should GxP audits be performed?

Audit frequency depends on your risk profile, regulatory requirements, and internal policies. We can help you develop a risk-based audit schedule that aligns with best practices based on industry standard risk-based inspection programs.

What do I receive after an audit?

You’ll receive a comprehensive report detailing observations, any compliance concerns, weaknesses and opportunities for improvement, and actionable recommendations. We also offer support to help you address any findings.

Why Choose EPiC for Your GXP Audits?

Ex-Regulatory Consultants: Our team is composed of former regulatory agency consultants, bringing insider knowledge and perspective to your audits. This unique background enables us to anticipate compliance concerns and advise on best practices that go beyond basic compliance.

Tailored Approach: Understanding that each organization is unique, we do not believe in a one-size-fits-all solution. Our audits are customized to meet your specific needs, challenges, and goals, ensuring meaningful and actionable insights.

Commitment to Quality: Quality is not just a regulatory requirement for us; it is a principle we live by. Our audits are thorough, transparent, and aimed at fostering continuous improvement, ensuring you achieve and maintain sustainable compliance.

Next Steps

Contact us today to learn more about how our GXP audit services can benefit your organisation or to schedule a consultation with one of our expert consultants.

Let us help you navigate the complexities of regulatory compliance and safeguard product quality and patient safety.