The Audit Sharing Working Group developed a process and supporting materials for an ongoing Rx-360 audit sharing program. The program launched in September. Companies (including suppliers) have started to send to the Secretariat, inquires of interest in participating in the program, as well as offers to share reports. The audit sharing process and other information on the Audit Sharing Program are available on the Rx-360 website or can be obtained from the Secretariat. All Rx-360 member companies are encouraged to participate in this program.
The Auditor Qualification Working Group continues to evaluate auditing firms for the Joint Audit Program. The selected auditing firms will be asked to provide pricing using a matrix, enabling the Secretariat to comparatively match firms to audits. The working group will work to complete the SOP.
With the completion of the final audit for the pilot program, the Audit Design Working Group is reviewing post audit questionnaires from participating auditors and suppliers. Feedback gathered will be compiled into a report and presented to the Board. The first post pilot audit was conducted in Japan mid-October. A report listing six audit requests moving forward in the process was circulated to the membership in November. The SOP for the Performance of Third Party Audits has been completed.
The Audit Standards Working Group The Packaging Subgroup has finalized its audit guide based on the ISO 15378 standard for primary packaging and will also consider the possibility of adopting the PS 9000:2011 guideline. The Supply Chain Security Subgroup revised the Supply Chain Security Audit Guide to provide more guidance to auditors regarding how to use the document, in response to feedback from the Joint Audits Pilot Program. The Audit Standards Working Group continues to liaise with EXCiPACTTM on use of the EXCiPACT standard for excipients, and is conducting a survey of the Rx-360 membership to identify priority guidelines and/or audit guides for adoption or development.
The Audit Database Working Group issued a Request for Proposals (RFP) at the beginning of December. Responses are due in early January. The RFP seeks information on vendor capabilities and pricing for (i) audit database software, (ii) hosting, and (iii) administration. A final decision on a long-term database solution will be made by the end of Q1 2012, for implementation during the remainder of 2012.
The Quality Management System (QMS) Working Group has finalized the QMS for the established Rx-360 audit programs. The Working Group is also working with audit program working group leaders to finalize SOPs for the audit programs. The Group has developed a detailed plan for transitioning the existing working groups to a consolidated Audit Operations Structure, which is being discussed by the audit program working group leaders.
The Monitoring and Reporting Working Group continues to promote rapid sharing of important regulatory, legislative and policy developments relevant to supply chain integrity and pharmaceutical quality by preparing timely summary analyses which are publicly available on the Rx-360 website. The Working Group also periodically prepares brief, high-level updates on regulatory updates of interest to Rx-360 community, but not directly related to supply chain issues. Since the beginning of 2011, the group has posted 52 summaries and they continue to serve as an important resource.
The Regulatory Affairs Working Group engages regulators around the world in order to facilitate constructive relationships and keep them informed of Rx-360’s activities. The Working Group, in coordination with the Board, works to ensure that Rx-360’s initiatives are aligned with regulators’ expectations and priorities and are keen to solicit and respond to feedback from regulators. Rx-360 has engaged with numerous regulatory representatives, including from PIC/S, US FDA, EMEA, MHRA, and Irish Medicines Board.
The External Relations Working Group continues to provide regular updates to the pharmaceutical, supply chain and regulatory communities with information on Rx-360’s activities. Rx-360 continues to attract new members. The Working Group is organizing presentations/booths at several upcoming conferences, including Informex USA 2012 (14-17 February 2012) in New Orleans. Rx-360 is sponsoring a Habitat for Humanity event on 14 February in New Orleans. To volunteer to help, please contact Dede Godstrey ([email protected]).
The Japan Supply Chain Working Group has been meeting regularly over the course of the year, mostly from March through the summer. The Group recently met to discuss the finding of a Japanese infant formula provider of low levels of Cesium in its product (well below the regulatory food limits) and the potential impacts on the bio-pharmaceutical industry. The group will meet again in February to discuss any current or emerging changes in regulatory requirements and industry activities related to the effects of the Japan earthquake/tsunami.
The Supply Chain Security Steering Committee was established in October. The Steering Committee has established four working groups on Management Systems (to identify the elements of mature supply chain security systems); Audits and Assessments of Third Party Providers; Market Monitoring; and Conveyance Risk Management. All working groups are meeting regularly and seek to have deliverables finished in early 2012.