This question is about quality management system.

Your name is Dr Schrute and you work for Dunder Mifflin, an OECD (GLP) (Good Laboratory Practice) recognised company based in Ipswich. An old colleague, Professor Lapin-Vance, has been developing a new drug to treat stroke (called Provasic). He wants you to run a 28-Day Repeat Dose Toxicity Study in Swiss mice. Provasic will be administered to the mice intravenously after it has been dissolved in phosphate-buffered saline. Professor Lapin-Vance is particularly interested in the histopathological impact on the kidneys and has organised for an OECD GLP recognised company, called Devlin-MacGregor, to assess all kidneys. The work at Devlin-MacGregor will be overseen by Dr Sykes. You have checked with your boss (Dr Kimble) and they have given you permission to conduct the study.

Following Day 1 of dosing, it is decided that the intravenous administration would most likely be improved if the mice were lightly anaesthetised (this was not previously stated in the Study Plan).

a) What needs to be prepared to ensure that this change is documented in accordance with OECD GLP?

b) Prepare a draft version of this document.