News

Risk Analysis in Case of Insufficient Process Validation

Risk analyses are an essential prerequisite prior to process validation. But how should inadequately validated processes be handled in retrospect? The FDA comments on this in a recent Warning Letter.

More
The first GMP-Song ever?

Perhaps the first GMP song? A somewhat unusual subject. Listen to an AI generated song about equipment qualification.

More
ECA Validation Group launches redesigned Website

The ECA Validation Group website has been extensively revised. Find out what has changed and what you will find on the new ECA Foundation Group website. Enjoy browsing the new look.

More
FDA criticises the Use of pharmaceutical Facilities for industrial Products

Recently, several Warning Letters have been published by the US FDA criticising the use of non-dedicated equipment for pharmaceutical and non-pharmaceutical products. In a recent Warning Letter, this is once again made very clear.

More
Results of ECA Survey about Artificial Intelligence in Equipment Qualification

How is Artificial IntelligenceI used in equipment qualificattion? This is a question the ECA wanted to clarify with a survey. The survey contained 8 questions. Altogether 60 participants completed the survey. In the following, you will find a summary of the questions asked and their answers.

More
FDA criticises Equipment Qualification and Process Validation

In a current Warning Letter, the FDA has criticised inadequate device qualification and deficiencies in process and cleaning validation. What does the FDA require?

More
FDA criticises Non-Application of Statistical Process Control (SPC) in Validation

With the introduction of the updated FDA guidance on process validation, a process validation life cycle was introduced in 2011. One of the stages in the cycle is the so-called Continued Process Verification as stage 3, which shows whether the process remains permanently in the validated state. In a recent Warning Letter, the FDA criticised the statistical process control at a drug manufacturer. What was criticised?

More
Responsibilities of Quality Assurance - FDA Perspective

Warning Letters from the US FDA provide an interesting guide to interpreting the FDA's CGMP regulations. A current Warning Letter shows interesting considerations of the FDA regarding the tasks of quality assurance. What does the FDA think?

More
Pharmaceuticals and Non-Pharmaceuticals on the same Equipment

Questions about the simultaneous use of pharmaceutical equipment for the manufacture of drugs and non-drugs come up again and again. You could also already read about this. In a recent Warning Letter, the FDA has now reaffirmed its position on this issue. What does it say?

More
Change Control and (Re)Validation - The FDA Perspective

The topic of revalidation is rarely found in the regulations. Ongoing/continued process verification has replaced regular revalidation (with exceptions in the sterile area). But what can happen after a change control? Read more about the FDA's opinion.

More
x
Search