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Auditing Services for Pharma & Life Sciences

What Are Auditing Services in Pharma?

Auditing services in the pharmaceutical and life sciences industry involve independent evaluations of systems, processes, facilities, and documentation to ensure compliance with GxP (GMP, GCP, GLP) standards and international regulatory requirements.

We provide comprehensive GxP auditing solutions to help you maintain quality, minimize risk, and remain inspection-ready — whether you are a sponsor, CRO, CMO, or laboratory.

Our Auditing Services

We offer a full range of customizable auditing solutions across clinical, manufacturing, and quality operations.

1. GMP Audits (Good Manufacturing Practice)

  • Internal GMP audits of facilities and systems

  • External audits of CMOs, API manufacturers, and packaging sites

  • Verification of manufacturing processes, data integrity, and documentation

  • Inspection readiness and mock audits

2. GCP Audits (Good Clinical Practice)

  • Clinical site audits

  • Sponsor and CRO system audits

  • Trial Master File (TMF) audits

  • Protocol compliance and informed consent process reviews

3. GLP Audits (Good Laboratory Practice)

  • Preclinical laboratory audits

  • Bioanalytical and toxicology lab compliance checks

  • Data integrity and method validation audits

4. Vendor & Third-Party Audits

  • Qualification and risk-based assessments of vendors (e.g., CROs, CMOs, labs)

  • Periodic performance audits

  • Quality agreements and CAPA follow-up support

5. Regulatory Inspection Readiness

  • FDA, EMA, MHRA, PMDA, and WHO audit preparedness

  • Mock inspections and gap analysis

  • Support in responding to 483s, warning letters, and deficiency observations

6. Data Integrity Audits

  • ALCOA+ principles verification (Attributable, Legible, Contemporaneous, Original, Accurate)

  • Review of electronic systems (e.g., LIMS, ERP, CDS)

  • Audit trails, metadata, and access controls assessment

7. Quality Management System (QMS) Audits

  • Review and evaluation of SOPs, change controls, deviations, CAPAs

  • Risk management and quality metrics evaluation

  • QMS maturity assessments and training recommendations

Global Compliance & Standards

We audit according to international regulatory standards, including:

  • ICH Guidelines (Q7, Q9, Q10, E6)

  • FDA 21 CFR Parts 11, 210, 211, 312, 820

  • EU GMP & GCP Guidelines

  • ISO 13485, 9001

  • WHO & PIC/S Requirements

Who We Serve

  • Pharmaceutical companies (innovator & generic)

  • Biotech firms

  • Contract Research Organizations (CROs)

  • Contract Manufacturing Organizations (CMOs)

  • Clinical trial sponsors and investigator sites

  • Analytical and preclinical labs

Why Choose Us?

  • ✔️ Certified GxP auditors with global experience

  • ✔️ Risk-based audit planning and execution

  • ✔️ Clear, actionable audit reports with CAPA guidance

  • ✔️ On-site and remote audit capabilities

  • ✔️ Confidential and objective third-party evaluations

📞 Get in Touch

Let us help you build a stronger quality foundation.
Contact us to schedule an audit or learn how we can support your compliance journey.

📧 Email: [company@shudarsana.com]

🔗 Related Services

 

  • Quality Assurance & Compliance

  • Regulatory Affairs

  • Vendor Qualification

  • GMP Documentation Support

  • Clinical Trial Oversight

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