The Rx-360 Audit Program is designed as a unique approach to executing audits using our Joint Audit Program^® as well as licensing already completed audit reports. The program is specifically designed by Rx-360 members to help reduce audit costs industry-wide and be adjunctive to your own supplier audit program.

Rx-360 as a non-profit follows a very defined step-by-step approach within the Joint Audit Program^®. Our approach ensures that confidentiality between all parties is protected and that all audit stakeholders are aligned on the audit specifics and process. In most cases due to that approach, it is very difficult to expedite an audit. Rx-360 however will always research opportunities to meet our member needs.

Rx-360 has a mission within our audit program, to reduce industry burden and costs associated with supplier auditing. Through the Rx-360 Joint Audit Program^® we can match sponsors confidentially for a specific audit. The sponsors ‘join’ together to have a single collaborative audit conducted, while Rx-360 maintains confidentiality for the sponsors. This allows for the cost of the audit to be shared among the sponsors, reducing cost burden for them, as well as overhead and time burden for the auditee.

Rx-360 does allow for sole sponsorship in some cases.

Rx-360 will proactively seek out co-sponsors on your behalf (confidentiality) through our membership and industry customers. Rx-360 will work with you on an appropriate timeline to secure co-sponsors that meets your needs and expectations.

In some cases, Rx-360 will allow for suppliers to sponsor an audit of their own facility (“self-sponsoring”).

Rx-360 will assist in managing the CAPA process to address observations that result from an Rx-360 audit, by proactively interfacing with all parties involved: the auditee, sponsors, and auditor, following the CAPA process through to completion. This management is a required component of the audit and cannot be removed or transferred.

As part of our non-profit mission, Rx-360 offers a unique credit program to our members that allows for audit expense to be greatly reduced through program utilization. For more information on the Rx-360 Credit program, please contact us directly at info@rx-360.org.

Rx-360 is dedicated to helping our members in every way possible. We are glad to discuss with the supplier the benefits of the Rx-360 Audit Program, and its value to them. Our hope is that this education allows us to conduct the audit, but if a previous audit request was already declined, our access may also be limited.

Rx-360 works with third party auditors around the world. The breadth of auditors allows for our members to choose a partner that best fits their needs.

Because of confidentiality among sponsors and protecting the scope of the audit, Rx-360 acts as the point communicator for the entire scope of work. Rx-360 directly handles all communication with sponsors, and is included in any direct communication between auditor and auditee.

Rx-360 audit reports are used by a variety of customers, and each specific user may have different ways of categorizing audit observations, we don’t want to impose any judgements of our own onto the levels of the observations. We allow the customers to categorize the observations individually, according to their own internal procedures. Rx-360 uses 2 categories for audit observations within the final report: “Potentially Critical”, and “Other”. The auditor determines whether any of the observations would be considered Potentially Critical, and if it is not, then it is considered Other.

No, auditees are not charged for an audit. Fees associated with Rx-360 audits are paid for by the audit sponsors.

All Rx-360 Audit Checklists are developed by our membership. They are wide-ranging and allow for Rx-360 to meet industry needs. For a complete list of our audit checklists please contact us directly at info@rx-360.org .

The Rx-360 Audit Program is open to all manufacturers and suppliers within the pharmaceutical industry. Rx-360 Members can receive discounts for services within the program, as well as specialized reports, access to the auditsPlus® Database, and inclusion in the Credit Program. For more information, please contact us at info@rx-360.org .

Rx-360 is a non-profit international consortium that maintains a library of audit reports that are derived from audits that Rx-360 has executed. As a service to the pharmaceutical industry, Rx-360 makes the reports available for licensing.

Rx-360 maintains the ownership of all audit reports. The difference between licensing and purchasing a report is found in that a license is granted based on permission from the auditee, in an effort, to protect confidentiality. Licensing also protects the distribution of the report versus purchasing which could be perceived as ownership. Rx-360 does not offer the purchasing of audit reports.

The Rx-360 License Program is open to members of the pharmaceutical community regardless of whether you are an Rx-360 member or not.

Rx-360 audit reports, when licensed, are only available to the licensee organization and their approved affiliates as defined in the Rx-360 License Agreement. The License Agreement must be signed before access to the audit report is granted.

The list price for an Rx-360 Audit is $5000.00. Rx-360 members or member affiliated licenses, receive a 50% discount.

That depends on the situation. The cost of an Rx-360 audit license is a set fee schedule. That fee schedule is based on the license being member affiliated or not. The cost of sponsoring an Rx-360 audit (AKA having Rx-360 execute an audit on your behalf) is variable based on several factors, such as number of co-sponsors, and scope of audit. For more information on audit sponsorship, and our license fee schedule, please contact Rx-360 at info@rx-360.org

Rx-360 will not license an audit report to anyone without the auditee granting permission for the report to be released to that particular requesting company.

The list of Licensable audit reports can be viewed via the Rx-360 website at www.rx-360.org, or by emailing us at info@rx-360.org for a sortable list.

The confidential details of the audit (including observation details) cannot be disclosed prior to the completion of the license transaction. However, Rx-360 can supply you with the redacted cover page of the audit report for your viewing. This will allow you to see the basic details about the audit: auditee address, audit date, scope and the materials that were audited. The intention is to provide you with sufficient information to make an informed decision to move forward with the license process or not.

Rx-360 members receive the licensed audit report package along with the invoice (after auditee permission has been secured and the License Agreement is executed). For companies who are not Rx-360 members, after auditee permission has been secured and the License Agreement is executed, the prepayment invoice will be provided; payment must be received by Rx-360 before we will deliver the licensed audit report package.

Rx-360 maintains all our audit reports within our library and they remain available for licensing indefinitely. Each report is listed with the date of the audit, and they do not inherently expire. Rx-360 relies on the licensee to recognize whether the date of the audit falls within their own internal compliance rules and regulations for validity. Rx-360 endeavors to secure re-audits at supplier sites in typical audit cycle frequencies, however customer sponsorship is what allows us to maintain a current audit library.

No, Rx-360 audits do not represent any kind of certification. They are audit reports made available for licensing in order to reduce industry audit burden. They do not inherently represent any formal status or certification.

When you license an audit report from Rx-360 you will receive: auditor qualifications, audit agenda, audit report, CAPA documentation (if applicable) and closing letter.

You may reach out to Rx-360 at info@rx-360.org to inquire about the License Program, the Audit Program in total, or how to become an Rx-360 Consortium Member.

Membership is open to any company whose activities relate to the research, development, marketing, distributing, or manufacture of pharmaceutical or biotechnology products, including research-based pharmaceutical companies, generic pharmaceutical companies, biotechnology companies, as well as suppliers of ingredients and components of pharmaceutical or biotechnology products and suppliers of services relating to the quality or safety of the pharmaceutical or biotechnology supply chain. If your organization does not fall into one of the described categories, please reach out to us to see if one of our affiliate memberships may be a fit.

Rx-360 has a variety of membership tiers to fit different organizations, based on size, type, and stage of the organization. For information on what tier your organization fits into, please contact Rx-360 directly.

Yes, you will automatically be enrolled into the Audit program, and be eligible for member only discount, the credit program, and member only specialized data and utilization reports.

Rx-360 members are permitted to use an Rx-360 member logo to identify themselves as Rx-360 members. Rx-360 does not otherwise license the use of the Rx-360 logo to third parties for any reason, and any unauthorized use of the logo by a third party should not be construed as indicating an endorsement by the Rx-360 Consortium.

Rx-360 maintains registered trademarks on its name (Rx-360), Joint Audit Program, and auditsPlus.