As a complete pipeline partner for pharmaceutical and biopharmaceutical companies, we currently undertake in excess of 200 customer audits each year, in addition to our standard FDA and EMEA audits, and see standardization of the audit process and the sharing of audit information as ways to significantly reduce both the time and cost burden, while maintaining audit standards. As a customer, we carry out audits of our suppliers and, like all companies, want to utilize our internal resources more efficiently and maximize our return on investment, while enhancing the integrity of our supply chain. While we consider each of our customers to be special and unique, our vast experience has told us that their audit requirements are often very similar.
What we hope to achieve through our participation in Rx-360 is to implement a degree of standardization so that the audit process becomes more cost effective, while maintaining or improving quality in a logical fashion. Throughout SAFC we receive thousands of requests for information and, while the lists of questions that customers send for audits aren’t always the same, there is a basis of consistency among them. There is currently no structure that lets us efficiently disseminate our information back to the customers so one of our goals is standardize and harmonize procedures, to make that process much more transparent and efficient.
The Rx-360 Standards Working Group
One of the sub-committees within Rx-360 that we sit on is focused on the standardization of audits and auditors and earlier this year we announced the launch of the Rx-360 pilot program to share existing sponsor audits (the "Audit Sharing Pilot").
One of the functions of the sub-committee, and Rx-360 as a whole, is to both teach and share, pulling out the essential aspects of an audit and putting that into a “here’s what we need to do” list.
Typically, on a three to four-day audit, the first few days are focused on the basics, such as the purity of water, the training, etc., which have to be undertaken before we can get to the more critical issues. When devising the audit sharing process, the sub-committee’s thinking was that we should capture that information and leverage what we already know. From SAFC’s point of view, as a supplier we would save on fewer audits and the time it takes to host them, while as a producer we would save by being a part of a consortium that can do 100 audits for the same cost in money or time that it would take my staff to do 20-30 audits.
The Audit Sharing Pilot Program
The Rx-360 audit sharing process has been designed to make available the wealth of supplier audit information that already exists within consortium member companies and the purpose of the initial pilot program is to determine the value to Rx-360 members of sharing existing audits, and the effectiveness of the auditsharing process.
The pilot program aims to collect audit reports and responses associated with 36 suppliers in several regions of the world -- North America, Europe, China, and
India. The Working Group has sent initial communications to these suppliers inviting them to participate in the pilot program and has been following-up with each supplier in recent weeks to confirm participation and discuss questions.
The work of the Audit Standards Working Group is split into several sub-groups, as there are a wide variety of standards which are required. The Audit Standards Working Group and its sub-groups consist of 27 participants from 19 different companies and organizations. There are six sub-groups: APIs, Excipients, Supply Chain Security, Basic Chemicals, Packaging and Print. Of these sub-groups the first four are active and standards are being finalised. Wherever possible, existing standards are being adopted and Rx360 is working closely with other organisations. For example, PQG/IPEC are in the process of updating the excipients standards.
The standards will be used in a pilot to prove the whole auditing process. The current thinking is that a minimum of three standards will be used within the pilot programme. These are likely to be: API, Excipients and Basic Chemicals, in conjunction with the Supply Chain Security checklist, which is to be used alongside all of the other standards.
Collaboration key to success
As an industry we need to recognize that spending an inordinate amount of time gathering the same information a hundred different ways, is not helpful or efficient. Similarly, if we have a hundred different customers auditing a single location, while 99 other facilities go unaudited, that’s not helping anybody either. Rx-360 is about not stepping away from your responsibilities, but being able to leverage and share information among companies. Safety is not supposed to be a competitive advantage- it is what we all have to achieve, and we have to achieve it together. By working collaboratively, we will get more data and richer data, in a more efficient manner, to make better decisions.