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Office of Pharmaceutical Science (OPS) Revision Date: May 1, 2007 Sections1 PurposeThe FDA Council for Pharmaceutical Quality (CPQ) established the Pharmaceutical Quality Standards Working Group (PQSWG) to coordinate and advise pharmaceutical programs in the development and recognition of standards, commensurate with the mission of the Agency. This charter describes the duties and responsibilities of the PQSWG, its membership, and its operating procedures. 2. SCOPE2.1 The Pharmaceutical Quality Standards Working Group reports to the Council for Pharmaceutical Quality through the Chair/Co-Chair. The PQSWG serves as a coordination and advisory group for FDA activities in the development and oversight of standards activities associated with pharmaceutical quality. 2.2 The coordination and advisory roles do not include program authority. It is not within the authority of the PQSWG to overrule the decision of any program unit on any regulatory or policy matter related to standards. 3. ORGANIZATION and RESPONSIBILITIES3.1 The Pharmaceutical Quality Standards Working Group is organized as follows: 3.1.1 The PQSWG is led by a Chair, or Co-Chairs, as appointed by the CPQ. 3.1.2 The PQSWG consists of representatives from: the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA). Additionally, members may be appointed from: Office of the Commissioner, International Affairs; and Agency Standards Coordinator. 3.1.3 Center/Office Directors or their designees appoint PQSWG members; 3.1.4 Other participants, observers, and consultants from within and outside the Agency may participate, when appropriate and approved by the Chair/Co-Chair (see 3.4.5), in the activities of the PQSWG. 3.2 The Pharmaceutical Quality Standards Working Group is responsible for: 3.2.1 Recommending the extent and level of participation in standards development organizations; 3.2.2 Serving an advisory role for programs that are discussing proposed government-unique standards, in order to meet the Agency’s responsibility for due diligence in standard development; 3.2.3 Acting as a conduit and advisory source for standards associated with pharmaceutical quality and appropriate for the mission of the Agency, including recommending appropriate standards for recognition; 3.2.4 Proposing priorities for standards development; 3.2.5 Establishing and dissolving Standards Task Groups (as necessary), for work on a specific task (e.g. a specific standard or standard development organization); 3.2.6 Establishing procedures for, and overseeing activity of, Standards Task Groups; 3.2.7 Resolving disputes from Standards Task Groups, where necessary; 3.2.8 Recommending areas where training and education on standards for pharmaceutical quality may be necessary; 3.2.9 Facilitating development of the annual standards report to NIST through education, as well as discussions at meetings of the PQSWG; 3.2.10 Addressing other tasks as assigned by CPQ; 3.2.11 Regularly reporting to CPQ, as needed or directed (by CPQ). 3.3 Members of the Pharmaceutical Quality Standards Working Group are responsible for: 3.3.1 Representing their organizational unit’s views on issues under consideration by the PQSWG; 3.3.2 Serving as the point of contact for communicating with their organizational unit, including their senior managers, deliberations of the PQSWG and obtaining their input; 3.3.3 Identifying standards discussed in their own organization unit and bringing to the PQSWG for coordination when necessary; 3.3.4 Identifying and securing the appropriate technical and operational input for PQSWG activities, when necessary; 3.3.5 Appointing representatives from their organizational unit to participate in Standards Task Groups, as deemed necessary by the PQSWG; 3.3.6 Recommending agenda items for meetings of the PQSWG; 3.3.7 Regular attendance or representation at meetings of the PQSWG. 3.4 The Chair/Co-Chairs of the Pharmaceutical Quality Standards Working Group is responsible for: 3.4.1 Providing an Executive Secretary and a Project Manager; 3.4.2 Representing the PQSWG at internal Agency meetings, including the CPQ, as necessary; 3.4.3 Communicating activities of the PQSWG, including recommendations, decisions, issues, action items, and other pertinent materials, to members of the PQSWG; 3.4.4 Setting the agenda for meetings of the PQSWG, with input from PQSWG members; 3.4.5 Inviting observers, consultants, and others to participate in the activities of the PQSWG, when appropriate. 3.5 The Project Manager of the Pharmaceutical Quality Standards Working Group is responsible for: 3.5.1 Documenting and communicating activities of the PQSWG, including recommendations, decisions, issues, action items, and other pertinent materials, to members of the PQSWG; 3.5.2 Arranging and organizing meeting logistics; 3.5.3 Distributing documents relevant to the activities of the PQSWG; 3.5.4 Preparing documents and papers as requested by the Chair/Co-Chair. 3.6 The Executive Secretary of the Pharmaceutical Quality Standards Working Group is responsible for: 3.6.1 Tracking progress of action items generated during the meetings of the PQSWG and following-up on those action items accordingly; 3.6.2 Suggesting agenda items as appropriate; 3.6.3 Serving as the focal point for the Task groups. 3.7 The Standards Task Groups are responsible for: 3.7.1 Reviewing and recommending standards as assigned; 3.7.2 Following procedures established by the PQSWG; 3.7.3 Developing consensus for items under consideration; 3.7.4 Regularly reporting to the PQSWG. 4 PROCEDURES4.1 Meetings of the Pharmaceutical Quality Standards Working Group 4.1.1 Meetings will be scheduled based on need and workload; 4.1.2 Meetings will generally be attended by members of the working group or their designees, but may be opened if necessary; 4.1.3 Minutes of the meetings will be concurred upon by the group, and may be made available to all staff. 4.2 Priorities for Standard Activities 4.2.1 In proposing priorities for standard development the PQSWG will consider: 4.2.1.1 Areas where standards do not exist but should; 4.2.1.2 Areas where standards exist but could benefit from significant revision (including standards deemed not appropriate for recognition); 4.2.1.3 Areas where development activities are ongoing but continued support is not recommended; 4.2.2 Input from staff/management should be sought as appropriate. 4.3 In recommending Standards for recognition the Pharmaceutical Quality Standards Working Group will: 4.3.1 Solicit expertise from Agency personnel for review, as appropriate; 4.3.2 Determine recommendation by consensus of the PQSWG; 4.3.3 Recommend a process for recognizing standards (FR Notice, MaPP, SOP, Guidance, etc.), in whole or in part (specific sections), and a timeline for doing so; 4.3.4 For standards that have been considered, but not recommended for recognition, document the rationale for use in the annual standards report. 4.4 Consensus of the Pharmaceutical Quality Standards Working Group 4.4.1 Deliberations of the PQSWG will generally be brought to closure by consensus; 4.4.2 Dissenting opinions will be documented accordingly; 4.4.3 Disputes will be resolved by the CPQ, as necessary. 5 RECORDS5.1 The Chair/Co-Chair will assure that the activities of the PQSWG, including recommendations, decisions, issues, action items, and other pertinent materials attributable to the PQSWG are documented and communicated to the PQSWG, as appropriate. 5.2 The PQSWG will review this Charter at least annually, based on experience gained by the Council and revise it as needed. 6 References6.1 SMG
Date created: February 6, 2006, updated January 28, 2008 |
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