Good Manufacturing Practices (GMP) Audit
Ensure compliance with regulatory requirements (e.g., FDA, EMA, WHO, MHRA), verify that manufacturing processes meet safety, quality, and efficacy standards, and identify gaps and areas for remediation before inspections or product release.
GMP audits may include the following:
⬣ Buildings & Facilities
⬣ Equipment & Maintenance
⬣ Control of components
⬣ Production & Process controls
⬣ Packaging & Labeling controls
⬣ Holding & Distribution
⬣ Laboratory controls
⬣ Organization & Personnel
⬣ Document control
⬣ Records & Reports
⬣ Material handling and inventory management
⬣ Change control, CAPA, deviation and OOS investigations
⬣ Data integrity and computerized systems validation
Good Clinical Practices (GCP) Audit
Ensure compliance with ICH E6(R2 & R3) guidelines and applicable regulatory authority requirements (FDA, EMA, MHRA, etc.), verify the protection of subject rights, safety, and well-being, confirm the integrity and credibility of clinical trial data, prepare for potential regulatory inspections.
GCP audits may include the following:
⬣ Informed consent process and documentation
⬣ Protocol adherence and deviations
⬣ Investigational product handling, storage, and accountability
⬣ IRB or IEC approval
⬣ Adverse event (AE/SAE) reporting and documentation
⬣ Investigator & Personnel qualifications and training
⬣ Trial Master File (paper/eTMF) completeness and organization
⬣ Data management, monitoring, and quality oversight activities
⬣ Records
⬣ Randomization procedures & unblinding
Good Laboratory Practices (GLP) Audit
Ensure compliance with 21 CFR Part 58 (U.S. FDA) and OECD GLP guidelines, confirm the integrity, reproducibility, and reliability of nonclinical safety study data, support regulatory submissions (e.g., IND, NDA, BLA, PMA) with validated preclinical data, and verify adherence to SOPs, protocols, and quality systems.
GLP audits may include the following:
⬣ Study protocols and adherence to them
⬣ Data integrity and raw data traceability
⬣ Personnel qualifications and training records
⬣ Equipment calibration, maintenance, and validation
⬣ Laboratory methods
⬣ Facilities
⬣ Test article receipt, characterization, storage, and accountability
⬣ Sample handling, chain of custody, and storage
⬣ Archiving of study data and reports
⬣ Quality Assurance (QA) unit independence and audit documentation
CAP/CLIA Audits
Ensure compliance with Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) regulatory standards to maintain operational integrity, safeguard patient outcomes, and prepare for federal or accrediting inspections.
Globiox’s CAP/CLIA audit services are designed to verify that laboratories meet CLIA regulatory requirements and CAP accreditation standards, evaluate test accuracy, quality control systems, and personnel qualifications and identify compliance gaps and implement effective corrective actions before official inspections.
CAP/CLIA audits may include the following:
⬣ Laboratory Environment & Safety
⬣ Equipment Calibration & Maintenance
⬣ Specimen Collection, Handling & Tracking
⬣ Pre-analytical, Analytical & Post-analytical Process Controls
⬣ Proficiency Testing & Performance Verification
⬣ Personnel Qualifications, Competency & Training
⬣ Quality Management Systems (QMS)
⬣ Document Control & SOP Compliance
⬣ Test Method Validation & Verification
⬣ Records, Logs & Audit Trails
⬣ Data Integrity & LIS/Computerized Systems Compliance
⬣ CAPA, Deviations, and Non-conformance Management
GCLP Audits
Ensure laboratory operations supporting clinical trials meet the combined standards of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Globiox’s GCLP audits provide a comprehensive evaluation of clinical laboratories to ensure data integrity, regulatory compliance, and fitness for clinical decision-making.
Our GCLP audit services are designed to assess compliance with GCLP guidelines as established by WHO, EMA, and other global regulatory authorities, ensure laboratories generate reliable, reproducible, and traceable clinical trial data, and identify gaps in laboratory systems that could compromise subject safety or data credibility.
GCLP audits may include the following:
⬣ Study protocols and adherence to them
⬣ Data integrity and raw data traceability
⬣ Personnel qualifications and training records
⬣ Equipment calibration, maintenance, and validation
⬣ Laboratory methods and SOPs
⬣ Facilities and environmental controls
⬣ Test article/sample receipt, characterization, storage, and accountability
⬣ Sample handling, chain of custody, and storage
⬣ Archiving of study data and reports
⬣ Quality Assurance (QA) unit independence and audit documentation
Globiox tailors each GCLP audit to the trial phase, therapeutic area, and sponsor requirements, helping clients mitigate risk, enhance regulatory confidence, and maintain compliance across the clinical research lifecycle.
GDP Audits
Ensure the quality and integrity of pharmaceutical products throughout the supply chain. Globiox’s GDP (Good Distribution Practice) audits assess compliance with international guidelines (e.g., EU GDP, WHO, FDA) to safeguard product safety, efficacy, and traceability from manufacturer to end user.
Our GDP audit services are designed to verify that distribution activities comply with GDP regulations and industry best practices, evaluate the robustness of storage, transportation, documentation, and risk management systems, and identify and mitigate vulnerabilities that could impact product quality or regulatory standing.
GCLP audits may include the following:
⬣ Premises & Warehousing Conditions
⬣ Temperature Mapping & Environmental Monitoring
⬣ Transportation Controls & Route Validation
⬣ Receipt, Storage, and Dispatch Procedures
⬣ Documentation Practices & Recordkeeping
⬣ Qualification of Suppliers and Customers
⬣ Handling of Returned, Rejected, or Recalled Products
⬣ Security Measures and Anti-Counterfeiting Controls
⬣ Personnel Training and Competency
⬣ Change Control, CAPA, and Deviation Management
⬣ Computerized Systems and Data Integrity
⬣ Risk Assessment and Quality System Oversight
Globiox’s GDP audits help pharmaceutical distributors, logistics providers, and wholesalers maintain regulatory compliance, reduce supply chain risks, and ensure product integrity across global markets.
REMS Audits
Assess compliance with FDA-approved Risk Evaluation and Mitigation Strategy (REMS) requirements, ensure that measures to mitigate serious drug risks are implemented and maintained as required, identify and remediate noncompliance that could jeopardize product approval or lead to regulatory action, and support ongoing REMS assessments submitted to the FDA (typically 18 months, 3 years, and 7 years post-approval).
REMS audits may include the following:
⬣ Review of REMS program design and operational elements
⬣ Evaluation of prescriber and pharmacy certification, training, and enrollment processes
⬣ Oversight of restricted distribution systems, including authorized distributors and specialty pharmacies
⬣ Verification of ETASU (Elements to Assure Safe Use) implementation (where applicable)
⬣ Review of communication plans to healthcare providers and patients
⬣ Inspection of data collection, reporting, and reconciliation processes for REMS compliance
⬣ Review of third-party vendors and REMS administrator
Custom Scope Audits
Address targeted compliance concerns in GMP, GCP, GLP, GDP, or GVP domains. Focus on high-risk areas, critical processes, or recent changes (e.g., new systems, acquisitions, CAPAs), align audit activities with regulatory inspection readiness, internal initiatives, or third-party oversight. We provide flexible and efficient auditing without the overhead of a full system audit.
Common use cases:
⬣ Post-merger/acquisition compliance baselining & harmonization
⬣ For-Cause audit
⬣ Verification of CAPA implementation or remediation effectiveness
⬣ Focused audits on data integrity, validation, or supply chain controls
⬣ Pre-inspection readiness for specific regulatory focus areas
⬣ Vendor audits with narrowed scope (e.g., IT infrastructure, warehousing, pharmacovigilance)
Mock FDA Inspection Readiness Audit
The purpose of an FDA mock inspection is to simulate an actual FDA inspection to evaluate organizational readiness, identify compliance gaps, documentation issues, and process weaknesses. These audits are aimed at reducing risk of FDA 483 observations or warning letters, and train personnel on inspection behavior, documentation practices, and Q&A response techniques.
Conducted by experienced auditors acting as FDA investigators, Globiox readiness audits follow a realistic inspection flow, including unannounced opening meeting simulation, request of documents and interviewing staff under FDA-like conditions, and review of records for completeness, accuracy, and inspection-readiness.