Working Group & case study Excerpts
View presentations and read excerpts from our Audit Program leaders and members at the 2023 Patient Safety Conference. Below you’ll learn about Rx-360’s SAQ Working Group, the value of the Joint Audit Program, and case studies from GSK and NewAge.
“We have developed a standard set of questions to be shared in use across companies, where the Rx-360 SAQs were developed to cover information that is included in most supplier questionnaires. We set them up that they [have] more data than most … this will decrease the number of times that you will have to fill out a questionnaire.”
“Questionnaires are great tools to collect data about your products of interest, and pharmaceutical manufacturers and government regulatory bodies require this information to determine product quality and its impact on patient safety. Over the years, the questionnaires have become more complex, [and a] broader scope of questions have been introduced. This forces each pharmaceutical manufacturer to create its own set of supply questionnaires, and they send them out to their suppliers. The suppliers then receive a multitude of different forms, need to answer the same questions on the same topics, [which] is inefficient and this has been recognized within the industry. Since 2014, Rx-360 developed questionnaires to have standardization in the industry … and we believe that the SAQs will create helpful efficiency for both suppliers and the pharmaceutical manufacturers, and we strongly encourage you to use out questionnaires for standard use.”
“I’ve seen a lot of different companies’ audit reports and they’re great, but nobody’s audit reports are as thorough and as in-depth as Rx-360’s … the bottom tagline, confidentiality. Confidentiality is very important to us at Rx-360. So if you’re sponsoring an audit, you won’t know who the other sponsors are.”
“One of the things that we try to do is to ease the burden on the supply chain, and one of those ways is to get some of those audit reports out there so that smaller companies ,who don’t have the resources or don’t spend enough money with a particular company to get into audit with them, can access these reports and actually have the information that they need. So as a nonprofit, Rx-360 contributes to member organizations’ corporate social responsibility efforts, aiding them to operate in an economically and socially sustainable manner … We’re not creating [audit] checklists out of thin air. We’re basing them off international regulatory requirements and standards, but that checklist generation is put together by different members of Rx-360’s working groups because they are experts in the field and they know what regulations they are audited to.”
“This year we’ve been able to generate over one hundred thousand ‘Rx-360 dollars’ that we can utilize for additional sponsored audits and licenses next year. It’s really been a good return on investment for us from a third party audit perspective … the more you use it, the more valuable it becomes.”
“Once you sponsor an audit and you’ve paid for that audit, it becomes licensable [and] those license fees can be credited back to you up to the full amount that you paid to sponsor that original audit. And then those ‘Rx-360 dollars’ can then be reused to sponsor other audits or to purchase licenses. So it essentially allows you to use your money twice, and get good value out of your third party audit budget … We’ve generated enough ‘Rx-360 dollars’ from our work to offset all of the sponsorship costs for audits this year, in addition to our membership dues, [which] is additional money that we can offset and use next year for further audits.”
“Rx-360 has brought a great deal of value to our organization and help advance our quality system while increasing our company presence … that for us is a $250,000 savings that we have been able to enjoy over the past two years. Not to mention it’s thirty less onsite audits that we’ve had to host.”
“So they [Rx-360] are really looking for the relationship building. We wanted something that would be able to maintain that, and also minimize some of the burden that was on us. The questions that were asked were deeper and more relevant, so they were specific to what we do and what our customers need from us. To be frank with you, some of the audits before weren’t diving deep at all, and when I sat through the Rx-360 audit, I was amazed at the questions they were asking and how deep they got into extrusion and molding, and the interplay with those … Rx-360 has brought a great deal of value to our organization and helped advance our quality system while increasing our company presence.”