News

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?

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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?

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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?

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Correlation between Validation Master Plan and Validation Protocols

In a news item from 12 March 2025, we described deficiencies in microbiological tests of non-sterile products. However, the warning letter in question provides further information: on process validation. What was criticized?

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FDA takes a Look at Cleaning Validation

In a recent GMP news, we pointed out deficiencies, especially regarding stability data, of an Indian manufacturer by referencing an FDA Warning Letter. This Warning Letter also offers interesting interpretation aids on the subject of cleaning validation. What is the FDA interested in?

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Process Validation Deficits in API Manufacturing

Interpretations of legally binding requirements in the GMP environment are provided by guidelines, guidance documents, etc. (soft law) or inspection results. The following are excerpts from an FDA Warning Letter to an API manufacturer regarding process validation deficiencies. What did the FDA criticize?

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Update of Training Material for ICH Q8, Q9 and Q10

In a detailed news article in late 2023, we referred to the new training package for the revision of the ICH Q9 guideline (quality risk management). The ICH has now published updated training material on the implementation of ICH Q8, Q9 and Q10.

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The ICH Q9 Briefing Package - a Forgotten Document?

Due to the revision of the ICH Q9 document on quality risk management, the ICH has also published comprehensive training material on the “main text”. However, even the revised version of the ICH Q9 (R1) document still has two annexes. Training slides that the ICH published as a “Briefing Package” in 2006 are still available on the ICH website, though. Is the "Briefing Package" still up to date?

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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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