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?
FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.
EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.
The European Medicines Agency, EMA, as well as the EDQM have extended their deadlines for submitting risk evaluations for Nitrosamine Impurities in medicinal products by the Marketing Authorisation Holders.
The European Medicines Agency (EMA) is urging the general public not to buy medicines from unauthorized websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic.
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain.
By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.
Testing for virus contamination plays an important role in blood and blood components. Recently, the FDA has published a guidance document on testing for T-lymphotropic viruses by means of serological testing.
The FDA has revised its assessments and recommendations to reduce the possible risk of transmission of Creuzfeldt-Jakob by blood and blood products.
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.