Due to the current Sars-CoV-2 outbreak, more and more people started working from home; this includes Qualified Persons (QPs). But what do the regulators say when it comes to batch certification?
Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?
Annex 21 to the EU-GMP Guidelines (Importation of medicinal Products) has been published as a draft. It summarises the GMP requirements for importers of medicinal products.
The EMA and its partners are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the EU.
After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.
