News

Are you familiar with the Verification Guide ASTM E 2500?- ECA Modern Qualification Survey Results

Last week part I of ECA´s survey about "Modern Qualification" was published. In the following you will find further results of ECA's survey on modern qualification.

More
FAT & SAT not frequently used as Part of Qualification - ECA Modern Qualification Survey Results

The ECA set up a survey to find out to what extent qualification and validation programmes are integrated as actually made possible by the EU Annex 15 and the FDA Process Validation guide – and to what extent suppliers are involved. Read more about the Qualification/Validation Survey results.

More
FDA criticises missing stage 3 in validation lifecycle

In a five-page warning letter to an OTC manufacturer, the US Food and Drug Administration (FDA) criticises, inter alia, the missing program for continued  process verification.

More
No second chance for a first impression - inspection result by a European supervisory agency

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.

More
FDA Requirements on Process Validation - a Warning Letter provides Information

The coming into force of the new FDA guidance on process validation in 2011 led to a shift in paradigm. Validation is a three-stage life cycle now and also includes commercial production in stage three. What does that mean for implementing the FDA proces validation guidance though? 

More
Ignoring Inspection Results doesn't pay off

After an FDA inspection with relevant results, the FDA usually expects a response within 15 days. What happens, however, if there is no response to the FDA inspection results?

More
Inspectors' Aide Memoire on Process Validation - a Detailed Analysis

With the Annex 15 revision, the issue of process validation became significantly more complicated. What is an authority's view on the topic of process validation?

More
What Will Change with the New GMP Directive?

The GMP directive is dead - long live the GMP directive. It was with this phrase that new kings were announced in France in order to demonstrate the monarchy's continuity. But what about content consistency between the old and the new directive? What are the differences between both GMP directives? What will change in the new GMP directive, what will stay the same?

More
European GMP Inspector discovers Cleaning and Process Validation Deficiencies

It's a well-known fact that the US FDA publishes GMP deficiencies in their Warning Letters. For some years now, there has also been a European portal, where non-compliance results are published. In August 2017, an Upper Bavarian supervisory agency has issued such a statement of non-compliance with GMP to an Indian manufacturer of medicinal products. Which deficiencies were found?

More
FDA criticises Process Validation Deficiencies

In a recent warning letter issued to "Wuxi Medical Instrument Factory", the FDA criticised deficiencies concerning process validation, amongst other things.

More
x
Search