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New FDA Guidelines: Batch Uniformity and Drug Product Integrity / Advanced Manufacturing Technologies

The U.S. Food and Drug Administration (FDA) has published two new documents: a draft guidance referred to as "Considerations for Complying with 21 CFR 211.110" and a final guidance for industry titled "Advanced Manufacturing Technologies Designation Program."

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Qualification Deficiencies from the FDA's Perspective

There is relatively little information on the FDA's requirements for equipment qualification. A current Warning letter provides guidance.

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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.

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The first GMP-Song ever?

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

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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.

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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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