20/21 March 2024
The results of a survey on Modern Qualification were summarised in FAT & SAT not frequently used as Part of Qualification and Are you familiar with the Verification Guide ASTM E 2500? According to these results, some companies repeat tests done during commissioning in qualification stages.
At ECA´s Modern Qualification and Validation Conference in September 2018 FDA´s Director Grace McNally also lectured about what the authority thinks about this topic. During this lecture she also mentioned that "per the preamble to 21 CFR Parts 210/211 the agency does not intend that the quality control unit (aka Quality Unit) duplicate functions that are “properly those of the engineering department or other specialized units because of their unique training and experience” (also see slide below).
In addition, alternatives to the classic DQ, IQ, OQ concept are possible as well. Grace McNally cited the ASTM E 2500 "Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment", as this standard is mentioned in a footnote of FDA´s Process Validiation Guidance.
All slides of Grace McNally's lecture are accessible to members in the ECA Validation Group website members' area. If you are not a member yet - it is free of charge; just use the online membership application. Moreover, as ECA member you can also find her presentation as well as the group's brandnew "Modern Qualification Guide - a guide to effective qualification based on Customer-Supplier Partnership" in the ECA members area. And if you want to comment on the guide, you are welcome to do so by 15th November. You will find the template for your comments also in the members' area.