Audits and Mock Inspections Ensuring Quality, Compliance & Patient Safety
Comprehensive Audit Services for Pharma, CMO and Clinical Trial Sites
01
GxP Supplier Audit
Quality System Audits:
Conduct a rigorous, risk-based evaluation of your external partners — from raw material providers to contract manufacturers and laboratories — to ensure full compliance with international regulatory standards such as FDA, EMA, ICH, WHO and MHRA; mitigate quality risks; and strengthen supplier and site oversight across the GxP spectrum.
Product/Process Specific Audits:
Assess critical operations processes to verify compliance with regulatory, quality and safety standards essential for pharmaceutical manufacturing. ex. Sterile Manufacturing Process (EU Annex1/CFR 211.113), API & Excipient Production (ICH Q7/EU part II), Packaging & Labelling (21CFR 211.122/EU Chapter 5&6), QC testing (21CFR211.160 -165/EU Chapter 6).
02
Internal Audits
Regulatory Compliance:
Verify ongoing compliance with EU and international GxP standards (e.g.,ICH Guidelines, WHO, PIC/S) regulatory requirements, internal procedures and quality standards by identifying gaps, risks and opportunities for improvement within the organization.
Continuous Quality Improvement:
Identifying systemic weaknesses, inefficiencies and risks. Foster a culture of quality excellence, optimize operational processes and maintain a state of perpetual readiness for regulatory inspections.
03
GMP & GCP Compliance Audits
GMP (Good Manufacturing Practice) Audit:
Systematic assessments and verification to ensure that suppliers operate in accordance with Good Manufacturing Practice (GMP) guidelines.
GCP (Good Clinical Practice) Audits:
systematic review of clinical trial processes and documentation to ensure compliance with regulatory requirements (EU Clinical Trials Regulation No 536/2014, Eudralex Vol.10, ICH E6(R2), ICH E8, WHO), ethical standards and the principles of Good Clinical Practice.
04
Audit Tracking & Monitoring
Audit Record Maintenance: Establishing a comprehensive audit tracking system for documentation and follow-up. Assess compliance to regulatory expectations, EU GMP Chapter 4, ICH EG (R2) section 8, FDA 21 CFR part 211.180 and Part 58.195.
Audit Findings & CAPA Tracking: Recording non-conformities and ensuring timely resolution through Corrective and Preventive Actions (CAPA). Continuous monitoring of supplier performance to sustain regulatory compliance.
Why Choose My GxP Audit Services
Extensive Industry Experience: In-depth knowledge of supplier auditing, GMP compliance and supplier relationship management.
Tailored Audit Solutions: Customized auditing strategies based on your supplier network and quality requirements.
Focus on Risk Reduction: Helping you maintain supplier quality while minimizing supply chain risks.
The Value of Audits in Pharma and Clinical Research
Supplier audits are a critical component of pharmaceutical quality assurance. They ensure that raw materials, packaging, outsourced manufacturing and Clinical Research meet the highest quality standards. Non-compliant suppliers can jeopardize your products, lead to regulatory actions and damage your brand reputation.
How My Audit Services Can Support Your Business
Ensure Supplier Compliance: Verify that suppliers meet GMP, GCP and regulatory expectations.
Strengthen Supply Chain Quality: Implement quality agreements and audit tracking systems and enforce CAPA procedures.
Cost Savings: While supplier audits require an investment, they can prevent costly issues down the line, such as product recalls, rework and legal battles. Proactive audits help identify and address potential problems before they escalate into major problems.
Audit-ready?
The 10 Most Common GMP Deficiencies – and How to Avoid Them
GMP inspections and internal audits are a critical milestone for biotech and ATMP companies.
Nevertheless, experience shows that even highly innovative companies regularly fail due to avoidable deficiencies.
This compact guide highlights the ten most common mistakes in GMP practice – based on over 20 years of QA experience.
With clear recommendations and an audit self-check to help you identify gaps at an early stage.
Get in Touch Today
Partner with an audit professional committed to ensuring your suppliers meet regulatory and quality standards. Contact me today to discuss your supplier audit requirements and learn how I can help safeguard your supply chain.
Strengthen your supplier quality and regulatory compliance today with expert Supplier Audit Services!