GMP News

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?

In February 2019, the FDA published a new draft guideline that addresses quality aspects of continuous pharmaceutical manufacturing. It covers topics related to development, process validation, marketing authorisation and routine production.

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.

FDA inspectors usually expect a minimum level of GMP understanding for identity and assay determinations of starting materials and finished products. Read here which basic GMP deficiencies in the quality control laboratory have led to a Warning Letter regarding incoming goods controls and testing of finished products.

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

With the publication EMA's guideline on Shared and Dedicated Facilities and the revision of Annex 15, the topic of cleaning validation has gained new attention. The PDE concept is now the determining factor. But what about the FDA?

Will EU-based pharmaceutical companies still be able to use a manufacturing site for which the GMP Certificate has been issued by a UK authority? The answer is yes - but with restrictions.

The FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.

The scope of the EU-FDA Mutual Recognition Agreement (MRA) will be extended to veterinary medicinal products, human vaccines and plasma derivatives.

Data from pre-clinical/clinical studies are often not sufficient for a comprehensive qualification of impurities with regard to their biological safety profile. The new EMA Reflection Paper provides guidance for determining the safety profile of impurities by means of various methods.

In response to the increasing need for a guidance paper for radiopharmaceuticals in non-clinical settings, the EMA has published a "Draft guideline on the non-clinical requirements for radiopharmaceuticals".