GMP NEWS 2022

Proposal for New General USP Chapter on Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides

In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.

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Pharmacovigilance Inspections Report

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.

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Safety Assessment of Clinical Trials

To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. The new Regulation will become applicable on 31 January 2022 - together with the Clinical Trials Regulation (EU) No 536/2014.

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CTIS - New Version of the Sponsor Handbook

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.

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EMA: Updates of the Q&A Documents for "Centralised Procedures"

In December 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised marketing authorization procedures on their website.

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USP Proposal for Contaminant Pyrrolizidine Alkaloids

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.

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Q&A Document on the QP Declaration revised

The CMDh has revised and published its Q&A document on the QP Declaration.

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Approved USP Chapters on Plastic Components used in Manufacturing

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.

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USP Draft Monograph for CBD

Because there is no existing USP monograph for this drug substance, a new monograph for Cannabidiol (CBD) is being proposed. It defines that CBD is obtained from Cannabis sativa.

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EU Commission amends Delegated Regulation on Safety Features again

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.

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Wholesale Distribution of Medicinal Products - Obligation to Notify Changes

Wholesale trading of medicinal products in Germany requires an authorisation according to Section 52a of the Medicinal Products Act (Arzneimittelgesetz – AMG). The holder of the authorisation must notify the competent authority in advance of any fundamental changes. A wholesaler from Brandenburg, Germany, did not comply with this notification requirement, as a GDP Non-Compliance Report published in October 2021 shows.

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The GDP Non-Compliance Reports of 2021 - An Overview

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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New Ph. Eur. Draft for COC

A revised draft for the new Ph. Eur. chapter 3.1.17. Cyclo-Olefin Copolymers (COC) has been published for comment in Pharmeuropa.

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Q&As: China GMP and Registration of APIs

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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Canada is working on Technical Cannabis Standards

Canada will lead an ISO international IWG to develop three technical guidelines for Cannabis including one on Good Production Practices (GPP).

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Requirements for Plastics in Pharmaceutical Equipment Engineering

Stainless steel is predominantly used in pharmaceutical equipment engineering. The 316L variant is basically regarded as standard; material incompatibilities of the steel with the product are more or less neglected. This is different with plastics. In addition to leach-out, aging and surface finish, other quality characteristics are often specified. But are there generally applicable requirements for plastics in pharmaceutical equipment engineering?

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Brexit and Northern Ireland - what's new?

In the course of the Brexit negotiations, the role of Northern Ireland was always in focus. The aim of the EU in particular was to avoid a hard border on the island of Ireland. Now there are further announcements and publications.

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