News

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
FDA criticises missing Step 3 in the Process Validation Cycle

Since publishing the FDA Process Validation Guidance in 2011, the FDA regards process validation as a three-step lifecycle. In a recent Warning Letter, the FDA criticises the absence of step 3 (Continued Process Verification).

More
ECA Validation Group - Update on Activities

The ECA Validation Group was established with the goal to gather knowledge on validation, for example by continuously developing a Process Validation Good Practice Guide. Find out more about what is new in the ECA Validation Group.

More
European authorities' viewpoint on validation deficiencies

An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.

More
Validation vs. Verification of Medical Devices - An Interesting FDA Warning Letter

It its cGMP regulations for medical devices (21 CFR 820 (Quality System Regulations), the FDA also addresses the topic of validation (21 CFR 820.75). In the course of its inspections, the authority reviews the validation of the manufacturing processes. The FDA criticised according deficiencies at a Taiwanese medical devices manufacturer with a Warning Letter.

More
Quo vadis Cleaning Validation in Annex 15?

In the draft revision of Annex 15 of the EU GMP Guide (Validation / Qualification) there were significant changes in the chapter on cleaning validation threshold determination. Which of these changes will still to be found in the final document? Read on here.

More
European Authority's Inspection Findings in the Area Validation/Qualification

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.

More
x
Search