Below are links to actual product recalls by regulatory authorities illustrating the contents of a recall document.
FDA Recall Example
IMB Recall Example
A qualified person (QP) is a technical term used in European Union pharmaceutical regulation (and therefore Ireland). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements. (EudraLex, Volume 4, Chapter 1). In the USA there is no specific requirement from the FDA for a person specifically called a “qualified person” but the FDA requires that a company selects someone who is qualified to be the person who signs off on batches.
From January 1st 2014 the Irish Medicines Board (IMB) will be known as the Health Products Regulatory Authority (HPRA).