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Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.

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Both the "IRIS guide to registration and RPIs" and the "IRIS guide for applicants" were updated in February and published on the EMA website.

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According to the GDP guidelines, regular self-inspections should be performed. But what is considered as an appropriate regular interval?

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In February 2022, the U.S. FDA issued a Warning Letter (WL) to an Indian drug manufacturing site called "Indiana Chem-Port" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

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The second version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in June 2021 and needs to be followed for API dossiers.

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The US Government Accountability Office (GAO) has released a report to Congress entitled "FDA Should Take Additional Steps to Improve Its Foreign Inspection Program".

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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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