Comprehensive Audit & Compliance Services

Compliance verification aligned with ICH Q7 and ICH Q9 risk management. Scope covers process controls, impurity profiles, change control procedures, batch record review, and quality unit oversight at active pharmaceutical ingredient manufacturing sites.

Material purity and traceability evaluations based on IPEC-PQG GMP standards. Assessing excipient manufacturers' quality systems, analytical testing methodologies, supplier qualification frameworks, and supply chain transparency documentation.

Structural and security printing reviews utilising PS9001 criteria. Covering primary and secondary packaging material specifications, tamper-evidence feature integrity, print quality control systems, and component traceability requirements.

Technical capability and quality framework verification before onboarding. Assessing manufacturing capacity, quality management systems, regulatory inspection history, batch release processes, and sub-contractor oversight mechanisms.

Specialised containment, sterility, and cryogenic-chain auditing for cell and gene therapy manufacturing lines. Covering aseptic processing controls, environmental monitoring programmes, cold chain management, and chain-of-custody for starting materials.

Evaluation of media fill protocols, environmental monitoring (EM) trend analysis, and particulate control systems. Aligned with EU GMP Annex 1 (revised 2022) and FDA aseptic processing guidance, covering cleanroom qualification and contamination control strategies.

Multi-departmental audits across Production, Warehouse, Quality Control, Engineering, and Quality Assurance functions. Structured to align with current CGMP requirements and provide a systematic assessment of internal quality management system compliance.

Focused deep-dive assessments to clear the regulatory runway before commercial drug launches. Includes data integrity forensic reviews, batch record completeness checks, process validation gap assessments, and benchmarking against current agency inspection trends.

Infrastructure and process evaluations meeting OECD GLP Principles and 21 CFR Part 58 requirements. Covering facility design and maintenance, study director oversight, raw data management, archiving procedures, and quality assurance unit function.

Quantitative verification of testing and calibration laboratory management systems. Assessing method validation documentation, equipment calibration schedules, reference material traceability, proficiency testing participation, and uncertainty of measurement reporting.

High-complexity data-integrity checks targeting genomic and biological laboratory assay pipelines. Covering method validation against EMA and FDA bioanalytical guidance, sample management procedures, instrument qualification, and data handling controls.

Verifying regulatory compliance at third-party contract research laboratories processing clinical trial samples. Assessing chain-of-custody controls, sample storage conditions, assay performance metrics, and data transfer integrity between vendor and sponsor systems.

Forensic, unannounced data deep-dives conducted during physical audits to identify software manual overwrites, audit trail deletions, user bias in result selection, and transcription vulnerabilities from instruments to laboratory information management systems (LIMS).

Verifying source traceability, wholesale dealer licencing, storage condition compliance, and diversion prevention controls under global pharmaceutical distribution mandates. Assessing procurement procedures, returns handling, and complaint management systems.

Reviewing continuous temperature tracking systems, excursion management procedures, and storage mapping validation for heat-sensitive biologics, vaccines, and biosimilar products. Covering qualification of cold rooms, refrigerators, and temperature-controlled vehicles.

Evaluating high-security vault storage specifications, narcotics tracking records, chain-of-custody documentation, and destruction procedure controls for Schedule I–V controlled substances across national and international regulatory requirements.

Auditing third-party logistics warehouses, ambient and refrigerated freight networks, and cross-docking operations. Assessing handling procedures, GDP training records, system interfaces with sponsor quality systems, and business continuity arrangements.

Foundational quality management system assessments covering context of the organisation, risk-based thinking, process approach implementation, customer focus, leadership engagement, and continual improvement mechanisms against ISO 9001:2015 requirements.

Information Security Management System assessments critical for demonstrating data protection posture to clients, regulators, and licensing partners. Covering risk assessment methodology, Annex A control implementation, and statement of applicability completeness.

Environmental Management System assessments evaluating environmental aspects and impacts, legal compliance registers, operational controls, emergency preparedness, and environmental performance monitoring against ISO 14001:2015 requirements.

Occupational health and safety management system assessments covering hazard identification, risk and opportunity evaluation, worker participation, operational planning, incident investigation, and performance evaluation under ISO 45001:2018.

Verification of digital vendor technology stacks against FDA 21 CFR Part 11 and EudraLex Annex 11. Assessing cloud infrastructure security, audit trail functionality, user access controls, backup and recovery procedures, and electronic signature compliance.

Evaluating vendor code repositories, change control tracking systems, bug remediation processes, regression testing coverage, and release management controls to assess the rigour and traceability of the software development lifecycle within regulated environments.

Retrospective auditing of existing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) scripts for missing evidence, inadequate test coverage, incomplete execution signatures, or weak performance parameters.

End-to-end mapping of data generation, processing, review, and archiving to ensure records remain Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available throughout their regulatory retention period.

Detailed auditing of transition points where operators transcribe physical instrument logs into digital systems. Identifies transcription vulnerabilities, manual entry opportunities, timestamp inconsistencies, and human bias in result transfer that compromise data integrity.

Verifying manufacturing site compliance with DSCSA product identifier requirements and EU FMD unique identifier specifications. Assessing barcoding equipment qualification, serialization system validation, aggregation process controls, and exception management procedures.

Auditing the secure electronic transfer of transaction information, transaction histories, and transaction statements between manufacturers, wholesale distributors, repackagers, and dispensers within the pharmaceutical supply chain information network.

High-definition live video facility walkthroughs, smart-glass-assisted equipment inspections, and secure cloud document parsing to execute rigorous audits without heavy travel. Particularly effective for document-intensive audits (TMF, PSMF, CSV), rapid supplier qualification checks, and cost-conscious SME clients. Each remote audit is scoped to match on-site rigour with appropriate technology controls.