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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.

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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.

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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?

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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?

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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?

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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?

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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.

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End Product Testing versus Process Validation

End product testing versus validation? This is a question that is frequently discussed in the GMP environment. The argument is that if the specification of the end product fits, which is even included in the marketing authorisation, then the process must also fit. Otherwise, no specification-compliant product would be manufactured. For the FDA this is a good example that this is not "state of the art".

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FDA Requirements for Process Validation

Inspection results often help with the interpretation of regulatory requirements. The FDA Warning Letters are a very good source for that purpose. A recent Warning Letter criticises deficiencies in process validation. What did the FDA object to?

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FDA Warning Letter Defines Minimum Criteria for Process Validation

In addition to 21 CFR 210/211 and the related Guides to Inspection of as well as Guidelines/Guidances for Industry, Warning Letters are another way of interpreting the US cGMP regulations. Read more here about FDA's response to a pharmaceutical manufacturer's reference to not being aware of the need to perform process validation.

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