Workshop on revised Annex 16: Unplanned deviations and QP discretion
by Richard Funnell, MHRA
The Interactive Workshop on revised Annex 16 posed several questions and tracked participant responses to questions on revised Annex 16.
When asked if they were aware of Section 5 on unplanned deviations, 31% of those polled answered “yes” while 69% answered “no.”
“Do you have a broad awareness of the contents of the revised Annex 16 recently published for public consumption. ”Yes” answered 47% of responders and 54% answered “no.”
When asked if they had a “broad picture” of the sections principles and content, only 30% answered “yes” with 70 % answering “no.”
When asked who felt that revised Annex 16’s inclusion in Section 5 was “broadly positive,” 71% responded that it was and 29% felt that it was not.
Two product quality scenarios were presented to workshop participants followed by the question “What would you do?”
The workshop ended with these questions and a request for feedback”
- Where is the revised Annex 16 better than the old one?
- Where do you think it is not as good?
- What is a positive aspect of Section 5 on unplanned deviations?
- What is a negative aspect of this section?
View the slides from this session here .