Document Details | Add Comment
Some changes are incorrect
||Croda Europe Ltd.
||Voter (363i1r2 - GMPs for Pharmaceutical Excipients)
||Section, Page, Line
||Section see document
Some alterations have undesirable consequences to the meaning of the clauses, or change the requirements in a manner that was not discussed in the meetings. Further details can be found in the appended word document. Some comments are editorial and this is made clear in the document.
|Submitter Proposed Solution|
See appended word document
Dear Dr. Moore:
Thank you for your vote and the comments submitted on behalf of EXCiPACT on the 363i1r2, Good Manufacturing Practices (GMP) for Pharmaceutical Excipients ballot.
The Joint Committee on Pharmaceutical Excipients has completed its review of all comments received on the 363i1r2 ballot language and has agreed to several editorial and substantive changes to the draft standard. As a result, a 363i1r3 ballot reflecting only the substantive changes agreed to by the Joint Committee will be opened in the near future.
I hope the above addresses your concerns. If you wish to change your vote, please contact Joan Hoffman, Secretariat by August 28, 2012 or sooner. If we do not hear from you by that date, we will presume you wish to maintain your negative vote and your issue was not resolved. If you have additional comments, or wish to discuss these points further, please contact me directly.
Thank you, again, for your thorough review.
Chair, Joint Committee on Pharmaceutical Excipients
cc: J. Hoffman
Supporting File: Zamora-Moore-8-14-2012.pdf