The GMP/GDP IWG at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, and how to make risk based decisions to avoid drug shortages.
Manufacturing and Importation Authorisation holders must not change the terms of the authorisation without prior approval of the authority. But also other GMP related changes require notification to the national competent authority.
Bizarre Warning Letter to Chinese Drug Manufacturer
Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.
Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.
Frequent GMP Violations in pharmaceutical Companies (1): Testing and Release for Distribution
More and more frequently, FDA inspectors find fundamental GMP deficits at facilities producing finished medicinal products. The following analysis of recent warning letters shows that the final testing of pharmaceutical products for compliance with the specifications can not always be taken for granted.
EMA updates Website on Mutual Recognition Agreements
The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.
Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.