Compendial Group Accomplishments
I. The NJPQCA Compendial Discussion Group will be composed of consistent contact representatives from participating companies.
II. Discussion Group Members can invite or involve others from within their company who would have the appropriate expertise or specialized knowledge to provide specific input on relevant issues applicable to the pharmaceutical industry as a whole.
III. The Discussion Group will meet on a monthly basis or as needed, preferably after the NJPQCA meeting, to discuss the issues in the current USP Pharmacopeial Forums allowing time for review of the publication within each company before the meeting.
IV. An agenda for Discussion Group meetings will be prepared by the designated Chair(s) at least one week prior to the meeting and e-mailed to Discussion Group Members. If additional issues are surfaced by any Discussion Group Member, these can be e-mailed to the other Discussion Group Members if there is sufficient time. If not, they can be brought up at the end of the meeting. Minutes will be issued by the Chair or designee and a short report will be given at the following NJPQCA meeting.
V. The Discussion Group will meet with the objective to share issues related to Compendial (USP and PhEur) proposals of a general nature (i.e. General Chapters/ Tests, General Notices, Excipients, Policies and Announcements/General Information, Stimuli Articles/Scientific Notes, Interim Revision Announcements/ Official Announcements-Rapid Implementation). The format for the discussion will be to ask for one Discussion Group Member to lead the discussion on a particular issue allowing for the following types of discussion to occur (i.e. impact, pros, cons, approaches).
VI. Each member company will select its individual approach with the Pharmacopoeias. If the Discussion Group Members decide that a formal recommendation is needed from the NJPQCA Compendial Discussion Group, it will be included in the minutes for comment/review. It will also be announced at the main NJPQCA meeting and a copy of the draft letter to the compendia will be available at that meeting and provided to all of the NJPQCA Executive Board members prior to sending the response to the compendia.
VII. The Discussion Group can also be utilized as a training/learning resource to share how Pharmacopoeias work, how different Compendial Committees operate and to share feedback from the Compendial Conferences. This may include visits to the Pharmacopoeias to discuss issues with their staff. The Discussion Group should ensure that at least one Member attends the USP Open Conferences and reports back to the Discussion Group.
VIII. The Discussion Group can also look at new analytical and instrumental technology or general test or informational chapters which the pharmaceutical industries would like to see adopted by the Compendia.
IX. Any charges for the meeting will be handled by NJPQCA.
Charter eff. October 18, 2000