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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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The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.

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The ICMRA has published a report on remote inspections with valuable advice for the pharmaceutical industry, also for its own preparation and implementation.

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At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.

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