Reasons to Buy into a Joint Auditing Program
Posted on August 17, 2022
At the time of writing, our manufacturing facility at Ilfracombe has back-to-back customer audits planned until March 2023. Book an audit now for our facility in Medemblik and you will be offered dates in November 2023. This is not due to inefficiency or the result of a major problem, it is simply the effect of biomanufacturers need for supply chain compliance and the fantastic growth in the biopharma market. Audit burden is now huge and affects both drug manufacturer and system supplier alike. Substantial growth, particularly for single-use systems, and speed to market brought about by the vaccine race, has triggered capacity expansion globally. So, can auditing be fast-tracked without compromising quality and accuracy? And if auditing as a process can be simplified, will it still fall within the tight boundaries set by regulatory authorities that help define Supply Chain Quality Management? The answer to both these questions is yes. The current way we, as an industry conduct audit processes, can be simplified by joint audit programs.
What is Joint Auditing?
We all know the importance of individual audits to demonstrate and verify compliance to standards and assure that services supplied comply to agreed specifications. But what exactly is a joint audit?
It is an audit by an independent auditing company representing multiple customers that can access the resulting audit report.
Although not an entirely new concept, the idea of joint audits and sharing audit data was put practically into motion for biomanufacturers, by BioPhorum, after recognition of the growth of single-use systems, expansion of existing sites and the recent explosion of new manufacturing facilities. Effectively this joint audit is a collaboration between biomanufacturers and suppliers with the primary objective: to relieve audit burden for both parties and standardize audit practice. At its best it is a united solution to an industry-wide pain point.
BioPhorum’s leadership in joint auditing took shape in the form of a successful four-year pilot trial involving eight biomanufacturing supplier sites, including Pall Hoegaarden in Belgium, and utilizing the Rx-360 organization to coordinate and standardize external auditors. Similar in nature to BioPhorum, Rx-360 is an international consortium addressing pharmaceutical and medicinal device supply chain security in relation to public health concerns and patient safety.
The success of this lengthy workstream pilot trial1 utilizing the Rx-360 Joint Audit Program® model has raised the profile of joint auditing as a viable alternative to individual audits. The ongoing result is a large number of international biopharma manufacturers, as interested parties, co-sponsoring an increasing number of external supplier audits. The tangible reward of this process is that each standardized audit becomes a licensable report that subject to approval, can be accessed by the many. In this way much of the pain of the process is diluted or removed without infringing upon quality, reliability, and accuracy. Of course, it could be argued that the unofficial part of auditing, is the physical ‘feel’ that individual auditors get when they undertake their own in-person audit as they gather understanding for how their supplier plant operates. To remove this opportunity for a manufacturer could be seen as detrimental to the bigger manufacturing picture and manufacturer-supplier relationship. There is some truth in this. However, face-to-face technical site walkarounds are an easy way to forge collaboration and understanding between drug manufacturer and supplier, leaving room for more focussed discussion on specific topics.
Benefits of Utilizing Joint Auditing Programs
The benefits to having access to licensable joint audit reports are primarily cost and time. Two very important commodities within the biopharma industry, especially during the pandemic and the post-pandemic world we find ourselves living in. Back-to-back audit burden is reaching close to 300 across multiple Pall sites globally. This gives a clear snapshot into what biopharm suppliers worldwide are potentially managing year on year. And this is increasing. For any individual company this could be a lengthy bottleneck slowing down a critical drug reaching the market. Joint audit reports effectively shorten the ‘audit queue’ and when complete, are immediately available through Rx-360. These reports are not only available for those co-sponsoring the audit but are licensable by all.
The benefits for us as a critical supplier to the industry is the efficiency gained by serving multiple customers at a time. It is this, confirmed by Pall Hoegaarden’s positive experience as part of the joint audit process, that has led to all of our single-use system manufacturing sites joining the program. Access to the reports available to license is via the Rx-360 organization with all licenses subject to a Non-Disclosure Agreement approval. Further detailed information can be found in our Acceleratorsm Documentation Center.
The standardized audit reporting documentation package for the Rx-360 JAP consists of:
• Audit Plan
• Final Audit Report
• Supplier Response to Non-Conformities
• Auditors Qualifications
• Closure Documentation
Audit Standardization to Continually Improve Supply Chain Management
We know that above all else, every audit report should confirm compliance, and highlight potential areas of non-conformity, giving room for continuous improvement. This is where audit report/audit process standardization is a clear asset. An aligned industry approach to single-use auditing brings with it consistency for drug manufacturers and suppliers alike. A progressive evolution raising the bar for quality. With this in mind, the Single-Use System Audit Guide (SUAG) developed for the pilot program (and freely available to industry) can become an industry wide tool for SUS purchaser, supplier, auditor and auditee.
So, can joint audits be more thorough than traditional individual audits? In some ways we should expect them to be – traditional audits are one day in length whereas each Rx-360 JAP utilized for the BioPhorum workstream pilot program was conducted over 2-3 days. This can be intense but delves deep into the detail. And with SUS in mind, although much of traditional individual auditing is often conducted as a review of Quality Management Systems at a high level to ensure the requirements of ISO9001 are met, the Rx-360 JAP expands on that, utilizing auditors who are SUS subject matter experts, clearly focussed on GMP requirements specific to SUS products. For the BioPhorum workstream pilot program and the Rx-360 JAPs that have followed since, this is a gamechanger, bringing customer expectation of a SUS manufacturer into full view, at a time when industry needs it most.
As suppliers and manufactures increasingly buy into joint audits as a cost and time saving process, the Rx-360 JAP style audit could, and probably should become an industry standard that continues to benefit all.
1. ‘Joint Audit Program pilot program summary report January 2021’, https://www.biophorum.com/download/joint-audit-program-pilot-program-summary/
Subscribe to our FREE newsletter