News

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.

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.

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.

A News from March 2014 reported about EMA's revised process validation guideline entitled "Guideline on process validation for finished products - information and data to be provided in regulatory submissions". Now, the EMA has surprinsingly published a new revision of its Process Validation Guideline.