GxP Audits & Assessments

Key Compliance Challenges

Organizations may face challenges such as:

• Maintaining compliance across multiple regulatory markets
• Identifying critical gaps before regulatory inspection
• Managing supplier and outsourced-service risks
• Ensuring consistent implementation of quality systems
• Maintaining data integrity across paper and electronic systems
• Monitoring GMP compliance across multiple facilities
• Managing recurring internal and external audit programs
• Evaluating new facilities, suppliers, or business partners
• Implementing timely and effective CAPA
• Maintaining continuous inspection readiness

Our Audit Approach

01 — Understand We understand the audit objective, business context, regulatory markets, facility or system scope, applicable standards, and client expectations. 02 — Plan A risk-based audit plan is developed with appropriate scope, agenda, focus areas, documentation requirements, and assessment criteria. 03 — Assess Our auditors evaluate the relevant facility, processes, systems, documents, records, and controls through interviews, walkthroughs, document review, and evidence verification. 04 — Evaluate Risk Observations are assessed based on their potential impact on product quality, patient safety, data integrity, regulatory compliance, and business continuity. 05 — Report MGS provides a clear, structured audit report describing observations, supporting evidence, risk significance, and areas requiring corrective action or improvement. 06 — Support Improvement Where required, MGS can support CAPA review, remediation planning, effectiveness assessment, and follow-up audits.

What Sets MGS Apart

Multidisciplinary Audit Expertise

Our audit teams can draw on expertise across quality, manufacturing, engineering, validation, laboratories, regulatory affairs, computerized systems, pharmacovigilance, and EHS.

Risk-Based Assessment

Audit focus is prioritized according to the potential impact on patient safety, product quality, data integrity, and regulatory compliance.

Practical & Actionable Findings

Our observations are designed to help clients understand not only what the gap is, but also why it matters and where improvement is needed.

Customized Audit Programs

Audit scope and methodology can be tailored according to the client’s facility, product, process, supplier, regulatory market, and business objectives.

Independent Perspective

MGS provides objective third-party assessments that help organizations identify risks that may not be apparent during routine internal activities.

End-to-End Support

Support can extend from initial gap assessment and audit preparation through remediation, CAPA review, inspection readiness, and follow-up assessment.

Regulatory & Compliance Perspective

Depending on the audit scope, MGS assessments may consider applicable requirements, guidance, and expectations associated with:

• US FDA
• WHO GMP
• EU GMP
• MHRA
• PIC/S
• TGA
• ANVISA
• ICH Guidelines
• Revised Schedule M
• GCP, GLP, GDP and GVP requirements
• Other applicable national and international regulatory expectations

Who We Support

Our audit and assessment services can support:

• Pharmaceutical manufacturers
• API and intermediate manufacturers
• Finished dosage form facilities
• Biopharmaceutical organizations
• Medical-device companies
• Clinical research facilities
• Contract manufacturing organizations
• Contract research organizations
• Testing and analytical laboratories
• Warehouses and distribution centers
• Suppliers and vendors
• Technology and computerized-system providers
• Other regulated life-sciences organizations