GMP NEWS 2019

Brexit: Handling Pharmacovigilance Data from the UK

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.

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Brexit: EU supports pharmaceutical Companies

In a letter, the EU Commission explains possible exemptions for future batch testing in the UK.

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Warning Letter due to Serious Deficiencies in Quality Control

FDA inspectors usually expect a minimum level of GMP understanding for identity and assay determinations of starting materials and finished products. Read here which basic GMP deficiencies in the quality control laboratory have led to a Warning Letter regarding incoming goods controls and testing of finished products.

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Test for bacterials Endotoxin - New EP Chapter on recombinant Factor C open for public Comments

The European Commission and the EDQM have published a new chapter of the European Pharmacopoeia for testing bacterial endotoxins with recombinant factor C (rFC) for public comment.

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EDQM updates Guidelines on the CEP Procedure

The EDQM has published four updated Public Documents on the revision, renewal or re-application of a CEP. Here you can find out what has to be considered when describing an API and its quality in a CEP application.

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Cleaning Validation under the View of the FDA

With the publication EMA's guideline on Shared and Dedicated Facilities and the revision of Annex 15, the topic of cleaning validation has gained new attention. The PDE concept is now the determining factor. But what about the FDA?

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Monographs on radiopharmaceutical preparations - Revised Guideline

At the beginning of the year, the EDQM published a revised version of its guidelines for the preparation of monographs on radiopharmaceutical preparations. It now includes a new section on method validation.

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Brexit: Will UK Inspection Reports and GMP Certificates still be valid?

Will EU-based pharmaceutical companies still be able to use a manufacturing site for which the GMP Certificate has been issued by a UK authority? The answer is yes - but with restrictions.

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Brexit: Safety Features & Multi-Country Packs

Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published  the answer to this and other related questions.

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US Track and Trace System

The FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.

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MHRA Pharmacovigilance Inspection Metrics

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018. 

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EU-FDA MRA to be expanded

The scope of the EU-FDA Mutual Recognition Agreement (MRA) will be extended to veterinary medicinal products, human vaccines and plasma derivatives.

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New WHO Guideline on "Cold Production of WFI"

In February 2019, the WHO published a new Guideline for comment on the production of WFI using non-distillation methods. Read more about the draft entitled "Production of Water for Injection by Means other than Distillation".

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EMA's Reflection Paper on the Qualification of Non-Genotoxic Impurities

Data from pre-clinical/clinical studies are often not sufficient for a comprehensive qualification of impurities with regard to their biological safety profile. The new EMA Reflection Paper provides guidance for determining the safety profile of impurities by means of various methods.

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Final FDA Guidance on Public Warning and Notification of Recalls

The FDA strengthens the process for issuing a public warning about a voluntary recall and for notification of recalls. Read more about FDA´s final guidance on Public Warning and Notification of Recalls.

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Radiopharmaceuticals - Draft Guideline on non-clinical Requirements

In response to the increasing need for a guidance paper for radiopharmaceuticals in non-clinical settings, the EMA has published a "Draft guideline on the non-clinical requirements for radiopharmaceuticals".

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FDA: New Steps to improve Supply Chain Security

The US Food and Drug Administration (FDA) is launching a new pilot project for enhanced tracing and verification approaches in the pharmaceutical distribution supply chain.

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Hard Brexit: UK amends GDP Regulations

To face a possible Hard Brexit, UK plans to amend EU GDP Guidance.

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Blockchain - what is it about?

Blockchain should be able to help solve the challenges of the increasingly complex sales system. But what is Blockchain anyway?

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FDA Guideline on Immunogenicity Testing of Therapeutic Protein Products published

In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".

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