GxP Auditing Services

Need assistance complying with FDA, European, or other global device, biopharma, or diagnostic regulations? We help create efficient and compliant GxP (i.e. GCP, GMP, and GLP) quality systems, third party vendor management plans, and risk management programs. Pearl Pathways will conduct a gap analysis first so we find your gaps before the regulating body does.

Pearl Pathways understands the importance of continuous compliance monitoring to ensure that your efforts are both current and effective. Our advisors possess extensive domestic (US) and international experience and can cover the entire supply chain from raw materials to finished product.

GCP Audits:

Conduct specialized GCP auditing focusing on the issues associated with Phase I facilities
Provide training and support SOP development associated with the current phase of development
Assess compliance with FDA/EU regulations and ICH guidelines
Evaluate the databases used to track SAEs and IND Safety Reports
Review procedures for site visits and associated documents, such as monitoring reports and logs
Review the content of SOPs to ensure procedures and systems used are in compliance with applicable guidelines and regulations
Evaluate medical laboratories used to support clinical trials

GMP Audits:

Audits of Sites, Suppliers, and Supporting laboratories
Audits appropriate for clinical trial and marketed products
Quality Systems
Validation
Remediation
FDA mock audits to help prepare for an FDA inspection that mimic the FDA GMP inspection process and provide an unbiased assessment of readiness for an actual FDA inspection
FDA prior approval inspection audits to evaluate the preparedness of manufacturing facilities for regulatory inspections and conducting gap analyses or internal GMP audits to identify problem areas in quality system complaint handling, design control, corrective action, and manufacturing processes
Gap analyses to determine current compliance with FDA regulations specific to determine compliance with current regulations

GLP Audits:

Assessment of laboratories, records, facilities, test articles, test systems, facilities, chain of custody
for compliance with GLP regulations
Laboratory evaluation (personnel training and records, materials, experimental or analytical documentation, etc.)
Laboratory facilities (inspection of sample collection, preparation and storage procedures, analytical procedures and raw data audit, QA documentation audit, etc.)
Review SOPs for compliance with international standards
Records, reports and record/sample retention

Areas of expertise across drugs, biologics, devices, diagnostics, nutraceuticals, dietary supplements, food, combo products, compounding pharmacies, and radio-pharma include:

Clinical—21 CFR Parts 50, 54, 56, 312, 314, 361, 14155

Manufacturing—21 CFR Parts 210, 211, 111, 820, 600, 601, 610

Non-Clinical—21 CFR Part 58

Electronic Records/Signatures—21 CFR Part 11

ISO—13485, 14155, 14971, 22716, 9000s, 62304, 15189, 17025

ICH—Q7A, E6, E2A

Compounding Pharmacy—USP 797

European Directives—2001/20/EC, 2005/28/EC

Canadian Medical Device Regulations— SOR-98-282

We also routinely assess quality frameworks that support quality management such as Lean, Six Sigma, and TQM.