As I understand it a Phase Plan is used to complement a Study Plan.
If there is information in the Study Plan relating to the test item (i.e. lot number) and this has not been included in the Phase Plan, can this be included in the GLP Phase report?
I think this is OK, but need confirmation?
Vanessa Grant 05/11/2020 17:25
The Study Plan covers the entire study including the delegated phase at the test site. A phase plan is not required by the GLPs or OECD No. 13 but is often used to supplement information relevant to the test site. It does not negate the need to follow the study plan so you are fine including the information on the test item in the report as it is relevant to your phase but do not include other details which are not relevant as you cannot confirm they occurred as detailed in the study plan. Hope this helps.
RQA GLP Committee 20/11/2020 09:30
Thank you Vanessa for your comprehensive response. We agree with your comments.
It is usual for a phase plan to be added to a study plan in the form of an amendment and therefore is incorporated into it.