GMP News

As May 2022 approaches, the need for guidance on the In Vitro Diagnostics Regulation (IVDR) is growing. Regarding the topic of companion diagnostics, the EMA published a draft document at the end of last year about the consultation procedure between the EMA and a Notified Body.

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.

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

Marketing authorisation holders of medicinal products that contain sartan or sartan derivatives as active ingredients are required to submit the results of the review of their products under the "Call for Review" via variation applications. Find out what requirements must be met in this regard in the CMDh's recently updated Q&A document.

The European Commission published an updated version of the Questions & Answers document relating to the Clinical Trials Regulation (EU) No 536/2014. What documentation is required in the application for the authorization of a clinical trial relating to GMP for IMPs?

The MHRA GVP inspectorate recently published the latest inspection metrics for the period from April 2020 to March 2021. All inspections in this period were conducted remotely. The largest number of findings in the reporting period related to quality management systems, followed by risk management, and ongoing safety evaluation.

The go-live date for the CTIS is 31 January 2022. In order to help sponsors prepare for using the CTIS, the EMA has now published a new version of the sponsor handbook.

A new USP chapter <1567> on pyrrolizidine alkaloids (PAs) is being proposed. It discusses some analytical methods and existing challenges to measure PA contaminants in herbal medicinal products.

The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.

In order to ensure that medicinal products continue to be marketed with a unique identifier (UI) in Northern Ireland, Cyprus, Ireland and Malta, the Commission further extends the temporary derogation from the requirement to decommission UIs of products exported to UK.

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.

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.