DCAT Value Chain Insights’ “5 Minutes With,” part of the DCAT Member Company Community section, features interviews with business and industry leaders on issues impacting the bio/pharmaceutical manufacturing value chain.

This “5 Minutes With” features Jim Fries, CEO of Rx-360, a global non-profit consortium composed of bio/pharma companies and suppliers focused on pharmaceutical supply-chain integrity and material quality in the interest of patient safety, to discuss the organization’s initiatives in this area.

Question: Rx-360 is composed of various working groups and committees, with one being the Supply Chain Security Steering Committee. Can you tell us about the work of this committee, and what issues/projects relating to supply-chain security are of particular importance under this Committee?

Fries (Rx-360): The Committee over the past year has discussed a variety of issues. It’s made up of a great cross-section of our membership, and it provides an opportunity for members to confidentially benchmark against each other, talk about best practices, and discuss topics affecting pharmaceutical supply-chain security. The group has recently expanded to subgroups that touch a variety of international geographies. In addition, we have a subgroup of the Steering Committee that specifically addresses regulatory guidance from around the world that affects supply-chain security and integrity; the group has published many country-specific updates that are provided to Rx-360 members. The Steering Committee itself does a great job and features guest speakers on pertinent topics such as counterfeiting, diversion, and importation challenges. The group has also published many papers over the years that can be used as industry resources, for example, the recent publication of Understanding the Threat of Illicit Medicines.

Question: One initiative of Rx-360 is the Joint Audit Program®, which facilitates a joint audit of a given supplier, the results of which can then be shared through a license to a Rx-360 member company. Can you explain how the joint audit program works both from a supplier perspective and a bio/pharma company perspective, how the audit is conducted, and how the results are certified/shared.

Fries (Rx-360): The Rx-360 Joint Audit Program® is incredibly unique to the industry. It allows for companies to work together in a confidential manner to have Rx-360 conduct audits on their behalf. The audit sponsors are blinded to each other, and Rx-360 utilizes exclusive agreements with third-party audit sources to conduct the audit. Once the audit is completed and distributed to the audit sponsors, it is also uploaded into our license library, which allows companies with the auditee’s permission to license the report in an effort to fulfill their internal quality requirements. As part of the process, Rx-360 works directly with suppliers or auditees to inform the industry of the report’s availability. Members and non-members can acquire an audit report license. Members receive a 50% discount versus non-members. All these steps truly reduce the financial burden of conducting and hosting an audit. Being a nonprofit, Rx-360 has also established a members-only credit program. Through the utilization of the Joint Audit Program®, any member can collect credits that can be used to conduct future audits or pay for audit licenses, helping the industry reduce financial burdens. As part of the program, Rx-360 works with the supplier and auditor to make sure any CAPAs (corrective and preventive actions) opened as a result of the audit are effectively planned for and corrected.

Question: How are these audits used by bio/pharma companies in addition to or with their own supplier audits? Are they used as a complementary information source for Tier 1 suppliers, and/or is the interest by bio/pharma companies to use for secondary and tertiary suppliers as well?  Are these audits both onsite and remote or a hybrid? How did the audit program functioned during the pandemic, and as pandemic restrictions are eased, will remote audits still be used either singularly or in tandem with onsite audits?

Fries (Rx-360): Companies utilize the Rx-360 Joint Audit Program® to support their own internal audit groups, and a wide range of suppliers use Rx-360 audit checklists developed by our membership. Regarding remote auditing, I think it’s here to stay; however, it will, potentially, be focused on lower-tier suppliers. I believe that, at the start of the pandemic, Rx-360 was a leader in this area, developing remote and hybrid processes for the industry, so momentum in quality was not lost. Rx-360 will continue to offer both onsite and remote audits. 

Question: Another working group in Rx-360 is the Supplier Quality Working Group. What are some of the key initiatives/projects currently from this group?

Fries (Rx-360): This is a great group that works diligently on a number of projects, most notably the Supplier Assessment Questionnaire (SAQ), which is one of the most highly used tools that Rx-360 provides the industry. It’s also a great way for pharma manufacturers and suppliers to interact confidentially, share ideas, and network as they are both involved in developing the SAQ. This tool was developed by the Rx-360 Supplier Quality Working Group to address the following concerns: customers and government regulatory bodies require adequate levels of information to determine the risk(s) of the supply chain, raw materials, components, and services used in the pharmaceutical industry. The time and labor required for every pharmaceutical manufacturer and supplier to create, maintain, and administer their own supply-chain assessment questionnaires is an inefficient use of resources. Suppliers of raw materials, components, and services are exhausting valuable resources by continuously completing various forms of the same questionnaires received by a multitude of customers. The SAQ contains six modules and covers standard topics that would be included in most supplier assessment questionnaires. These questionnaires are more detailed than most, which ensures a reduction in the number of questionnaires requiring completion by the supplier. This significantly reduces turnaround time, thereby creating a more efficient process and improving the customer experience.

Question: Rx-360 also has working groups focused geographically in the supply chain (i.e., India, Asia Pacific, Europe, Latin America, Africa). Can you provide some highlights of the projects/initiatives from these groups?

Fries (Rx-360): This is a new expansion for 2022. In reality, it’s necessary, as each region has different, yet similar, challenges. Our goal is to work with our membership to identify these challenges, share the information industry-wide, and hopefully have an international summit event, where these group can get together and openly share their differences and commonalities in an effort to internationally improve pharma supply-chain integrity.