GMP News - Quality Assurance

The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.

In the context of data integrity, copies and how to deal with them play a central role. How are copies defined, what do the regulations require and what does an inspector expect?

You can't actually believe what you read in the Form 483 that the FDA issued to the Emergent BioSolutions site in Baltimore - the site that suffered a mix-up in the manufacture of a Covid-19 vaccine.

FIFO, FEFO and LIFO are the three main strategies for warehouse management. But what do the three abbreviations actually stand for and what exactly do they mean?

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and  Drug and Biological Product  Inspections During COVID-19 Public  Health Emergency Questions and Answers Guidance for Industry" with some further clarifications.

The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs.