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The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 18 January 2022 into the EudraGMDP database.

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In order to support its members, but also to support the industry in general in implementing the requirement of the upcoming revised Annex 1 for a Contamination Control Strategy, the ECA has published a CCS Guideline. This document provides guidance and a template for the development of a contamination control strategy.

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In January 2022, the U.S. FDA issued a Warning Letter to an Indian drug manufacturing site called "Aurobindo Pharmaceutical Limited" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

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The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian drug manufacturer. During an inspection, it was observed that the firm combined returned capsules from various lots into new batches, resulting in new lots with no uniform character and quality. The FDA also criticizes the firm’s stability programme and validation activities.

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Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?

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The FDA announced that the agency is adjusting its planned inspection activities to the spread of the Omicron variant and has therefore temporarily postponed certain inspection activities.

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Recently the U.S. Food and Drug Administration (FDA) issued a warning letter due to inadequate investigations into out-of-specification (OOS) test results.

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Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. For your information please see the comprehensive overview of the GDP non-compliance reports entered in 2021 and the respective reasons for issuing them.

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In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers' team.

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In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.

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