Pharmaceutical and biotechnology companies are held to extremely stringent standards, which require audits both internally and externally to maintain compliance with their Quality Management System (QMS). While internal resources can be deployed to conduct audits, there are many circumstances and advantages to contract expert consultants.
Pace® Life Sciences supports various functions across the drug product lifecycle, which includes GXP compliance consulting. Our GXP consulting professionals perform third-party internal and supplier audits, benchmarking and gap analysis, quality improvement, inspection readiness and critical phase inspections, amongst other related offerings.
Find more information about our auditing services here:
This white paper explores the advantages of engaging expert consultants for GXP (Good Manufacturing Practices (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP) supplier and internal audits in the pharmaceutical/biotech industries. It highlights how consultants bring specialized skills, objectivity, and efficiency to the entire audit process, ultimately contributing to improved compliance, risk management, and operational excellence for the companies that contract them to perform audits on their behalf.
Julie Barnhill, PhD | Senior Consultant
Julie Barnhill, PhD, Senior Consultant, is highly experienced in GXP quality assurance. Julie has a proven track record of implementing and managing robust compliance and quality systems and managing FDA regulatory inspections and quality compliance. Julie has supported a variety of pharmaceutical and biotechnology companies spanning virtual companies to industry leaders helping all her clients accelerate their pipelines in a compliant manner. Julie received her PhD in Bioinorganic Chemistry from the University of Pennsylvania.