Overview
Welcome to the Supplier Quality Working Group
The Supplier-Led Working Group is an Rx-360 working group consisting of members from both pharmaceutical companies and leading suppliers to the pharmaceutical industry. Through this Working Group, both pharmaceutical and supplier members share perspectives and work collaboratively to achieve greater efficiencies in the supply chain and to better serve patients in the long-term.
The Supplier Quality Working Group is currently working on module 5 – single-use systems. We are currently seeking members for this group.
If you are interested in joining this Working Group please contact us at info@rx-360.org
Watch thESE Brief Member TestimonialS
“I’m a very active member in the supplier quality working group. It’s benefited me by being able to be part of the solution by helping to shape the quality and regulatory compliance landscape that we all have to work within.”
Jennifer Goodman, Senior Director of Quality at Avantor
“Being a part of the Supplier Quality Working group is amazing, number one for networking and meeting new people. And the second is having a chance to collaborate with our industries because in the end, it’s impact to the patients, right? So, we want to make sure we have information available and everybody can use the resources we make sure are possible and available for everybody.”
Karla Longo Gouveia, Supplier Quality Management at Merck
Technical Visit Guidelines for the Biopharmaceutical Industry
Get guidance from subject matter experts on the requirements, execution, and management of the “technical visit”, as a tool in the supplier quality manager’s toolbox, and as it compares to the “quality audit”. The publication […]
SAQ
The Life of an Rx-360 Auditor by Kristen Hedrick
the Life of an Rx-360 Auditor by Kristen Hedrick
Take a look behind the curtain around the audit process for a rare glimpse into the rhythm, rigor, and realities of auditing in the pharmaceutical and life sciences industry.
📋 What Is an Audit?
At its core, an audit is “an official inspection of an organization to established requirements.” While financial audits often steal the spotlight, the session emphasized that audits come in many forms—each vital to maintaining compliance, quality, and trust across the supply chain.
🎥The Audit Process Unpacked + Pro Tips
1. Assignment
- Once the Rx-360 Scheduling & Execution team assigns an audit, the auditor receives a notification email.
- This email includes key background details, such as audit number, location, and dates.
2. Pre-Audit Prep
- Review previous audit reports, findings, and CAPAs (Corrective and Preventive Actions).
- Review requested products and special/confidential requests made by sponsor(s), as listed on the Statement of Work (originally captured via the Intent to Sponsor form process).
- Draft and refine the Audit Plan, incorporating Rx-360 Quality and auditee feedback.
- Prepare the audit report template and update background info.
Rx-360 audits are different, because we always involve our auditees in the development of the scope, audit duration, and audit agenda. Throughout the lifecycle of the audit, Rx-360 maintains open communication with the auditee and audit sponsors to ensure the audit will be as successful as possible and that the audit report has maximum listenability.
3. Booking Audit Travel Pro Tips:
- Research the site’s location, nearby hotels, and airports. Often, sites have special deals with hotel or rental car chains, so communicating with the auditee for travel recommendations can also be beneficial.
- Plan to arrive the day before and depart the day after the audit.
- Minimize layovers and maximize flexibility to handle delays or cancellations and avoid disruptions to the audit process.
4. Auditing
- Begin with check-in and an opening meeting.
- Conduct a facility tour and review documents (e.g., SOPs, floor plans, process maps).
- Wrap up with a closing meeting to summarize findings.
Rx-360 recommends that senior leadership and representatives from departments with stake in observations attend closing meetings. Rx-360 provides a detailed “Preliminary Observations” form to the audit team within three days of the closing meeting, so that all stakeholders – whether present for the closing meetings or not – are informed.
5. Post-Audit Work
- Share preliminary observations.
- Draft the audit report and gather feedback.
- Finalize the report and review CAPA responses.
Rx-360’s review process for the audit reports makes our audits different. After Rx-360 prepares the draft audit report, the auditee has seven calendar days to review the report and provide feedback. Once feedback is received, the auditor addresses the comments and then the draft audit report goes under a technical review by the Rx-360 quality team. Once the review is complete, the draft audit report is sent to the sponsors for review and comment.
💬 Final Thoughts
We’ve given just the foundation for understanding the audit journey—from assignment to final report.
Stay tuned for more from our auditor, and don’t forget to send in your questions. The Rx-360 team is listening—and learning right alongside you.
SUBMIT A REQUEST FOR AN RX-360 AUDIT NOW