Freyr Supports Global GxP Compliance Audits for French Multinational Pharmaceutical Company: Audits Over 90 Vendors

Business Imperatives

A French multinational pharmaceutical company, headquartered in Paris, engaged Freyr to conduct GxP compliance audits for its vendors. 
The audits encompassed the evaluation of vendor service facilities, vendor manufacturing facilities, and the processes and inter-relationship between the parent company and vendors. 
They sought Freyr due to their lack of in-house expertise in GxP service requirements and compliance.

Support was required for GxP compliance audits for its vendors that include auditing of: 

The customer lacked a developed or in-use management system to oversee the current system and services. 
There was a lack of in-house expertise to perform GxP audits. 
The audit plan scope had to be changed due to changing customer requirements, leading to a change of sites. 
Many vendors were spread across the globe, posing logistical challenges.

An audit calendar was prepared. 
Audit specialists were assigned based on GxP. 
Auditors were trained in customer-specific audit processes and templates. 
Periodic status reports were provided to the parent company. 
The on-site audit model was converted to a remote audit model during COVID-19 to ensure audits were conducted according to the audit calendar.

Audit Checklist: Created a checklist based on Regulatory requirements, industry best practices, and internal quality standards. 
Schedule Audit: Coordinate with the auditee to schedule the audit at a mutually convenient time. 
Perform Audit: Conducted the audit according to the predetermined checklist. Interviewed personnel, observed processes, and reviewed documentation to assess compliance with GxP requirements.  
Communicate Audit Findings: Held an exit meeting with the auditee to discuss preliminary findings and observations. Provided an opportunity for the auditee to respond to findings and clarify any discrepancies. 
Prepare Audit Report: Documented audit findings, including observations, non-conformities, and areas of improvement, in a comprehensive audit report.

Support was provided for GxP compliance audits for the vendors, covering auditing of vendor service facilities, vendor manufacturing facilities, processes and inter-relationships between the parent company and vendors. 
Comprehensive audits were successfully conducted, ensuring adherence to Regulatory standards across all vendor operations. 
Identified areas for improvement and optimization in vendor operations to enhance overall compliance and quality standards within the pharmaceutical supply chain.