The final version of ICH’s drug substance development and manufacturing guideline Q11 is nearing Step 4 clearance by the regulatory agencies in the three ICH regions following some significant changes the Expert Working Group (EWG) has made to the Step 2 draft based on the comments received.
Over 1,300 individual comments came in from the three regions during the comment period that ended in September. After removing duplicates, the EWG had about 200 comments to evaluate during the Step 3 review. That work was completed in Seville, Spain, in November, and the EWG has agreed on the content of a “pre-Step 4” document that will now go to regulatory agencies in the ICH regions for approval.
At the APIC/CEFIC meeting in Munich, Germany in mid-November, Q11 rapporteur Brian Withers (Abbott, UK), reported on the results of the EWG discussions that took place in Seville. He pointed out that there were “a lot of supportive comments” among those received, as well as others that prompted the EWG to make some “major” changes to the Step two draft.
In his presentation in Munich, Withers discussed Q11’s history and scope, the general public comments on the Step 2 document, and changes made as a result of the comments received.
Modifications were made in the sections of the guideline addressing: ● manufacturing process development ● manufacturing description ● commercially available chemicals ● starting materials and their submission ● control strategy ● process validation ● CTD submissions, and ● lifecycle management.
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