GMP News

U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs. This document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place.

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UK: Public Consultation on new Clinical Trials Legislation and Impact on IMPs

Following the start of the application of the EU CTR on 31 January 2022, the MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Will the UK align with the EU CTR requirements, e.g. regarding labelling of IMPs?

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Revision of the PIC/S GMP Guide

The PIC/S (Pharmaceutical Inspection Co-operation Scheme) already published a new version of its GMP Guide PE016 in February. This is due to the revision of the EU regulation on clinical trials. There is also a new annex on certification by a Qualified Person and batch release.

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Will there be an EU Herbal Monograph for Cannabis?

EMA´s HMPC announced the start of several activities relating to regulatory requirements and standards for medical cannabis. Amongst others, the HMPC will establish some basic information regarding existing standard requirements for herbal medicinal products (HMPs).

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Proposal for Slightly Revised USP Chapter <711> Dissolution Published

In the Pharmacopeial Forum, PF 48(2), a proposal for a slightly revised Chapter <711> Dissolution was published. The purpose of the revision is to include an option of using a new USP Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.

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