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Aseptic Process Simulation/Media Fill also under Scrutiny during European GMP Inspections

The ECA regularly publishes deficiencies identified by the US FDA during its inspections and subsequently published in Warning Letters. The European Union equivalent is the so-called Non-Compliance Reports, which are published via the EudraGMDP database. A recent statement by the French supervisory authority describes deficiencies at a Chinese manufacturer of biosimilars. What did the French authority find?

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FDA: Next Step to Reduce Animal Based Testing Methods

The use of alternatives to animal testing is increasingly becoming a focus for medicines regulatory and supervisory authorities worldwide. On 21 September, the FDA published an update on this matter.

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CCS in Practice: Is your Cleanroom Cleaning really under Control?

A Contamination Control Strategy (CCS) in a company covers many areas. Some aspects, such as the classical topics from Annex 1, are quickly recognized as part of a CCS. However, other areas are also affected that do not immediately stand out when one looks only at the chapter headings of Annex 1. One such topic that we would like to briefly touch on today is the outsourcing of activities related to cleaning and disinfection.

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What is meant by a Contamination Control Strategy (CCS) as defined in Annex 1 of the EU GMP Guidelines?

What is a 'Contamination Control Strategy', where is it required, who does it affect, and how can a CCS be established within a company? This brief summary provides information on requirements, content, regulatory background and practical approaches.

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Validation of Microbiological Methods - What do I need to bear in Mind?

When using microbiological methods in quality control or quality assurance, the question of method validation usually comes up, along with whether and to what extent this is required. A number of guidelines and technical documents provide guidance.

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Microbiological Contamination Control of Non-Sterile Medicinal Products – EMA Q&A

Contamination control measures also play an important role in the case of non-sterile medicines. A new Q&A from the EMA answers questions on this topic.

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Endotoxin Test – Updated FDA Q&A document published

With the publication of a revised Q&A guide, the FDA is responding to the recommendations on endotoxin testing set out in USP chapters <85> and <161> and in the AAMI guidelines for medical devices.

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Significant Deficiencies in Microbiological and Analytical Quality Control

A warning letter from the FDA highlights the importance of microbiological and analytical testing of medicinal products. For example, it criticises inadequate testing of culture media with GPT and a lack of BCC testing.

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Warning Letter: Microbiological OOS and Inadequate Microbiological Method Validation

In December, the FDA published a Warning Letter to a manufacturer of OTC products, in which it identified deficiencies in both the handling of microbiological deviations and the validation of alternative rapid microbiological methods. The testing and analysis of raw materials used for contamination was also inadequate.

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Become a Speaker at PharmaLab 2026 - Analytic, Bioanalytic, Microbiology

PharmaLab 2026 - become a speaker at the leading congress on analytics, bioanalytics and microbiology. Meet over 500 colleagues as part of the speaker team in Darmstadt (near Frankfurt Airport). We also welcome poster requests.

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