The changing face of Vendor management in the Pharmaceutical Industry

The past couple of years have seen a considerable shift in how we approach planning and executing our vendor management programs. The transition to working remotely in many facets of business life and the normalisation of the use of online meeting platforms to bring together teams that would have previously travelled to meet face to face at business meetings.  This new reality is visible none more so than in how we complete our audit programs.  There are numerous options to conduct audits remotely, and it is essential to have the right tools and prepare for success.  

Reminiscing from audits in Spain, Italy, Austria and of course the dream team in India!

Selecting the type of Audit
Remote audits may not suit every situation, and the first step is to assess whether an onsite audit is required or if a virtual audit would be appropriate.  The initial assessment of a new critical supplier or facility to determine if the quality management system is adequate and the site capable of manufacturing or storing the product to be supplied may require an in-depth multi-day onsite audit.  The company and its QPs/RPs need to get a feel for the general levels of housekeeping, cleanliness, and maintenance. They must determine if the facility is well designed and laid out and has the capacity to manufacture or hold the volumes required to GMDP standards.  Follow up routine audits of suppliers initially deemed GMP/GDP compliant (with minimal observations from the initial assessment) would be lower risk. In this situation, it would be appropriate to conduct a remote audit.  The most essential tool in determining what type of audit to complete is the periodic audit risk assessment.  The company should assess the risks associated with individual new suppliers through the change control program and determine if an onsite audit or virtual audit should be added to the audit program.  Also, periodically the entire program should be assessed to determine if the types of audits are appropriate and if in-person visits or virtual assessments can be completed.

​Tools and audit planning
For each assessment, we must determine how to complete any proposed audits.  If an on-site evaluation is to be carried out, then the audit must be booked months in advance with the site, as it is a more substantial drain on their resources to host an on-site audit.  

For virtual audits, it is critical to plan for success and ensure the site to be audited will have appropriate recording equipment and adequate broadband/Wi-Fi availability to allow the entire site to be visited virtually.  It is also essential to verify with the site to ensure that SOP’s, records, data and other documentation can be shared with the auditor using a secure data sharing program such as OneDrive or SharePoint.   Often suppliers who supply large numbers of customers and who, as a result, have frequent audits will have detailed documentation packs and walkthrough videos prepared that can enhance this process.  This will allow the initial site tour and document reviews to be completed offline and free up the auditees.  The interviews of key personnel and question and answer sessions can then follow this.

Audit Completion
The organisation needs to determine who will conduct the audit or audits, assess their capabilities and approve the individual plans or audit programs.  Also, an evaluation of whether to use their in-house team, QP/RPs or engage outsourced specialist consultants will be required.
Orion Consulting has a panel of highly experienced auditors with many decades of GxP, laboratory, and facility assessment experience. We can work closely to identify the right expert for your audit requirements, whether supplier assessments, storage sites, testing laboratories or internal or external manufacturing sites.
If you need an immediate assessment of your audit program or have a critical or urgent audit that you need to address then, please contact us at info@orionconsulting.ie