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?
The monograph "Cannabis Extract, Standardized" (Cannabis extractum normatum) will be added to the German Pharmacopoeia (DAB 2020).
The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 7: How to handle Legacy Systems if no audit trail is available or a "user login" is not possible?
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.