Rx-360

What it is

"The Rx-360 Joint Audit Program® is designed as a unique approach to executing audits using our Joint Audit Program® as well as licensing already completed audit reports."

Rx-360's FAQ takes up the question of what hosting an audit means for a supplier, and answers: "No, Rx-360 audits do not represent any kind of certification."

A sponsor receives a defined package. The programme overview lists it as "auditor qualifications, audit agenda, audit report, CAPA documentation (if applicable) and closing letter." Observations in the report are classed as Potentially Critical or Other.

There are two ways in. A sponsoring company can join an audit that is already open — "Co-sponsoring Rx-360 audits means sharing costs with multiple sponsors that are pursuing the same audit." — or request a proposal for a new one. The overview page also names confidentially cosponsoring, sole sponsoring and self sponsoring audits, and outsourcing CAPA management.

Reports are licensed, not published, and the audited party controls that: "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." Access is limited to the licensee organization and its approved affiliates as defined in the Rx-360 License Agreement.

The audit library is reached through the auditsPLUS® portal, which sits behind a login. What Rx-360 does publish openly is its member list, issued as a quarterly PDF — the Q2 2026 edition names the member companies (opened 3 September 2026).

Rx-360 states that membership is open to any company whose activities relate to the research, development, marketing, distributing or manufacture of pharmaceutical or biotechnology products.

Who owns it

"Yes, Rx-360 operates as a 501c6 nonprofit based in Philadelphia, PA (United States)."

The about page traces the consortium to a 2008 meeting with the FDA CDER director Janet Woodcock after the heparin contamination, and states: "After this meeting, Rx-360 was formed."

"Our mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of its materials."

The about page names regional working groups for Latin America, Asia Pacific, Africa & Middle East, India and Europe.

Who assesses it

"Rx-360 works with third party auditors around the world."

"All Rx-360 Audit Checklists are developed by our membership."

No public list of those third-party audit firms was found on the owner's pages opened for this record (3 September 2026).

Audit categories on the owner's sponsorship form

• API/Active Pharmaceutical Ingredient
• Excipient
• Single Use Systems
• Basic Chemicals/Raw Material
• Contract Laboratory
• GDP/Good Distribution Practices
• IT/SaaS
• Medical Devices
• Primary Packaging
• Secondary Packaging
• Other

Validity

Rx-360's FAQ answers the expiry question in full: "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."