Rx-360 Completes Pilot Audit of Manufacturing Facility: An Industry Case Study from Avantor - Pharmaceutical Technology

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Rx-360 Completes Pilot Audit of Manufacturing Facility: An Industry Case Study from Avantor
Avantor reviews its experience with the Rx-360 shared audit pilot program, which is aimed at protecting the pharmaceutical supply chain. This article is part of a special issue on Outsourcing.

Pharmaceutical Technology
Volume 35, pp. s59-s60

The Avantor audit

Rx–360's Auditor Qualification Working Group selected the third-party, accredited auditors based on a rigorous selection process. Criteria included education and experience with GMP products and training. Two auditors spent two days at Avantor's Phillipsburg manufacturing facility. Four quality department managers from the Avantor site were involved in the audit. In addition, the auditors engaged with additional company experts (e.g., senior validation manager, plant manager, global director of procurement) as needed. The focus of the audit was on the facility's production and shipment of pharmaceutical excipients as well as several highly regulated products: benzyl alcohol; potassium phosphate and potassium nitrate; and hydrochloric acid.

The Phillipsburg plant hosts 40 to 50 audits each year, with each industry audit averaging one day. Using Rx–360's standards, the audit included an evaluation of site security, quality-management procedures, manufacturing operations, packaging and labeling processes, information-technology security, and organization and personnel awareness (2, 3). After receiving an overview of Avantor's quality systems, the auditors toured the Phillipsburg plant. They were shown the complete processes and procedures for the four chemicals noted above, from receiving raw materials through to packaging and shipping final product. The auditors reviewed batch-production records and analytical-testing procedures for packaged material in its final form to ensure for the consistency, quality, and stability on several lots of product. In addition, the auditors reviewed facility documentation to search for any nonconformances. Staff-training records as well as maintenance and calibration records for processes and equipment were also reviewed. Within 30 days of the audit, Rx–360 provided Avantor with a report stating that the company has completed the audit with no critical observations. Rx–360 has since shared the audit with its members.

Lessons learned and the future of Rx–360

Rx–360 expects to audit more facilities as part of its pilot audit program, which will be completed by early 2012. The audit reports and program results will be closely examined by members of the consortium to determine the final qualifications of a standardized procedure for future audits (4). The audit was beneficial because it allowed Avantor to view its manufacturing processes through a lens that combined most industry audit standards into one comprehensive and stringent audit. Avantor is pleased to have completed the audit with no critical findings. Once the pilot is complete, the consortium will focus on amassing a repository of audits for the industry to share, with the goal that manufacturers can replace individual audits with those conducted by Rx–360 (4). In the long run, suppliers and manufacturers will ideally be able to invest more time and resources into advancing security.

Paul Smaltz is executive vice-president for Pharmaceuticals and the Americas at Avantor and an Rx–360 Board Member. Rick Siberski is global director of Quality Assurance and a member of the Rx-360 Auditor Qualification Working Group.


1. Rx–360 website, http://www.rx-360.org/, accessed July 8, 2011.

2. Excipact, Draft Excipient GMP Standard, April 2011.

3. IPEC/PQG, GMP Audit Guide for Pharmaceutical Excipients (2007).

4. Information according to Rx–360 Chair Lynne Byers.

Read a whitepaper from Avantor on this subject (PDF).


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