Below is a brief update on several Rx-360 Working Groups:
The Audit Sharing Working Group to date has received 58 audit reports from suppliers. The reports are currently being reviewed by sponsors so they may redact additional information deemed sensitive or confidential. A few of the reports have been returned to the secretariat and these will be uploaded into the Rx-360 database in early February. The working group is anticipating additional redacted audit reports from suppliers.
The Auditor Qualification Working Group has reviewed the received cost proposals and selected three auditing firms for the Joint Audit Pilot Program, to conduct audits in Asia, Europe and North America. Communications have been sent to the firms not selected to participate in the Pilot. A training/orientation session for the auditors has been conducted under the guidance of the QMS WG. Additional sessions are being planned to prepare auditors for the Rx-360 Pilot.
The Audit Design Working Group. The Secretariat has collected missing information about suppliers of APIs, excipients and raw materials/basic chemicals selected for the Pilot (e.g., contact info, site location, materials manufactured at specific sites). The WG leaders participated in the training/orientation session for auditors and answered questions. Pilot-Evaluation questionnaires have been developed for sponsors, suppliers and auditors.
The Audit Standards Working Group activities are focused on drafting an appendix to the Raw Materials and Basic Chemicals audit guide that will address chromatography resins. The Resins Subgroup has met several times via teleconference and plans to finish the appendix by Spring. The Packaging Subgroup continues to look into existing guidelines or standards that may be of use for Rx-360 packaging audits, and is monitoring progress of the PS 9000:2010 guideline for packaging
The Audit Database Working Group issued a Request for Information to obtain more information about options for a long-term database for the Rx-360 audit programs. The Working Group will review the information provided and, following consultation with the Rx-360 Board, issue a Request for Proposals. In parallel, the temporary database to be used during the pilot audit programs is up-and-running, and the Working Group will evaluate and implement change requests to this database as they come in.
The Quality Management System (QMS) Working Group developed and held an auditor orientation session with selected auditors for the Joint Audits Pilot Program and leaders from the Audit Standards, Auditor Qualification and Audit Design working groups. The orientation program is also available on the SharePoint site for auditors so that they may access documents and information at any time. A follow up question and answer session may be provided based on feedback from auditors. The QMS Working Group is also developing the quality management system for the post-pilot audit programs and will be holding concurrent in-person meetings in the UK and in the US to draft sections of this document.
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 group posted 2 dozen summaries during 2010 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 planning for two Open Meetings to be held at Chemspec (Thursday, 5 May http://www.chemspecevents.com/usa/ ) in Philadelphia, PA and ExcipientFest (Wednesday, 11 May http://www.excipientfest.com/ ) in Baltimore, MD.