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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?

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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?

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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.

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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.

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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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