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).