Comprehensive Quality Audit Services for Regulatory Excellence

Ensuring Compliance, Mitigating Risks, and Driving Operational Excellence

At MePharma, quality isn’t just a standard—it’s a commitment. Our Quality Audit Services offer a comprehensive, independent evaluation of your organization’s processes, systems, and compliance with GxP (Good Practice) standards. Designed for pharmaceutical, biotech, cosmetic, and healthcare organizations, our audits help you safeguard patient and consumer safety, uphold regulatory compliance, and continuously improve operational performance.

🛠️ What Our Quality Audits Cover

✅ 1. GxP Compliance Audits

We assess compliance across:

• GMP (Good Manufacturing Practice)
• GLP (Good Laboratory Practice)
• GCP (Good Clinical Practice)
• GDP (Good Distribution Practice)
• ISO Standards and regulatory authority expectations (e.g., SFDA, MOHAP, EMA, FDA)

Our audits cover manufacturing, packaging, testing, warehousing, and more.

✅ 2. Internal Quality System Audits

Evaluate your Quality Management System (QMS) for:

• Document control and SOPs
• Deviation handling and CAPA implementation
• Change management and training systems
• Data integrity and recordkeeping

We ensure your system is inspection-ready and aligned with global best practices.

✅ 3. Supplier and Third-Party Audits

Assess your external partners to ensure:

• Raw material and component compliance
• Adequate quality oversight and traceability
• Proper certifications, hygiene standards, and transportation conditions

Avoid weak links in your supply chain with third-party audit validation.

✅ 4. Audit Support and Readiness Programs

We prepare your team and facility for:

• Health authority inspections (local & global)
• Pre-approval inspections (PAIs)
• ISO certification and recertification
• Client or partner-driven audits

From mock audits to full documentation reviews, we ensure audit readiness at every level.

📋 Our Quality Audit Process

🔍 1. Audit Planning

We define audit scope, objectives, timelines, and compliance benchmarks.

🧾 2. On-Site or Remote Execution

Our qualified auditors conduct thorough assessments through interviews, walkthroughs, and document reviews.

📊 3. Findings & Reporting

A clear, actionable audit report outlines observations, non-conformities, and recommended corrective actions.

🔄 4. CAPA Follow-Up & Validation

We assist in implementing and validating corrective actions to close gaps and strengthen your QMS.

🚀 Why Quality Audits Matter

• 🛡️ Ensure Regulatory Compliance
• Stay aligned with international and regional authorities to avoid warnings, penalties, or market access issues.
• ⚠️ Mitigate Operational Risks
• Identify gaps before they escalate—protect product quality and company reputation.
• 🔄 Drive Continuous Improvement
• Use audit findings to optimize processes, reduce costs, and strengthen efficiency.
• 📈 Enhance Market Credibility
• Demonstrate to regulators, partners, and clients that you operate at the highest standards.

🤝 Why Choose MePharma for Quality Audits?

• ✔️ Deep expertise in pharma, biotech, and cosmetic sectors
• ✔️ Auditors with global regulatory experience
• ✔️ Tailored services for SMEs and multinationals
• ✔️ Transparent reporting and proactive support

📩 Partner with Us for a Culture of Compliance and Quality

Ready to assess, improve, and elevate your quality systems? MePharma’s Quality Audit Services provide you with the insights and assurance you need to succeed in highly regulated environments.

📞 Contact us today to schedule a consultation or audit briefing.