News

Validation Group Developments May through August 2025

Please see the ECA Validation Group's report on what they were working on and what they accomplished between May and August 2025.

More
Documented Evidence - a fundamental Principle at the FDA

Documented evidence is a fundamental principle of the FDA in the GMP environment. A recent Warning Letter illustrates this using the example of a lack of cleaning validation. What does the FDA expect?

More
FDA Warning Letter for both missing Process and Cleaning Validation

The FDA's current process validation guideline has been in force since 2011. The issue of cross-contamination has been mentioned in 21 CFR 211 since 1978, and the FDA Guide to Inspections on Cleaning Validation dates back to 1993. Process and cleaning validation have therefore been established procedures in the pharmaceutical environment for a long time. But what happens if neither process nor cleaning validation is in place during an FDA inspection?

More
Ongoing/Continued Process Verification - The Perspective of an European GMP Inspector

The introduction of a process validation life cycle brought a new element into play: ongoing/continued process verification. Although it has been known for at least 10 years, this stage still poses a challenge for the pharmaceutical industry. As part of an ECA course on this topic, Dr Franz Schönfeld, an European GMP inspector, presented his perspective on the matter. What does he expect?

More
Statistical Process Control (SPC) in a Restaurant - an universal Application

Statistical process control in restaurants? What does this subject line mean? It refers to a brochure published by Donald J. Wheeler, a world-renowned SPC expert, which describes the universal application of quality techniques and statistical process control in restaurants in a very interesting way. How was this done?

More
Revalidation - the FDA Perspective

With the FDA Process Validation Guidance for Industry coming into effect, stage 3 in the process validation life cycle ('Continued Process Verification') replaced regular revalidation in the non-sterile area. However, revalidations may of course be conducted on an ad hoc basis. A recent Warning Letter provides some guidance on what the FDA expects in such cases.

More
Survey Results: The Use of DoE in the Pharmaceutical Industry - Part I

Design of Experiments (DoE) is mentioned as a method in various ICH guidelines and in a chapter on the European Pharmacopoeia. Is DoE already being used in the pharmaceutical industry and in the manufacture of active pharmaceutical ingredients? The ECA wanted to evaluate this by means of a survey. Read the results in Part I on the outcome of the survey.

More
Media Fill and Smoke Studies: FDA's Perspective

In a previous News we reported on deficiencies in media fills. The topic is a priority for the FDA! In a recent Warning Letter, media fills were criticised again, as well as deficiencies in smoke studies. What did the FDA criticise?

More
FDA expectations for Media Fills

In a recent Warning Letter, the FDA criticised the lack of Media Fills. What does the FDA expect from Media Fills?

More
Qualification of old installations in 2025

Until the revision of Annex 15 in October 2015, Annex 15 contained a separate chapter on the topic of qualification of existing installations. This chapter was omitted in the new version. But how do you deal with the qualification of an old installation nowadays?

More
x
Search