GMP News

Hard Brexit: Liability Risk for Carriers

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

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Delivery of not ordered goods - what to do?

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

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FDA´s Pilot Program for Established Conditions

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

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Is the review of the Audit Trail required in Clinical trials?

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

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Short Format Development Safety Update Report

Not all trials are the same in terms of risk. Therefore, the MHRA proposesd a simpler and shorter form in lieu of a full Development Safety Update Report, giving a significant time saving.

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Focus on Cannabis in INCB´s Report for 2018

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

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Revision of the Swiss Drug Law - an Overview

The revised Swiss HMG came into force on 1 January 2019 - with some interesting GMP/GDP-relevant changes.

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Current Q&A on the MRA EU-FDA

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

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Warning Letter: FDA criticises Supplier Qualification

The full programme is part of a recent FDA Warning Letter, which the FDA sent to a manufacturer in the US only in February: Supplier Qualification, contract management, release procedure.

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Audit Trail Review required before Each Batch Release?

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?

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EU Commission: How to prepare for a "Hard Brexit"

The European Commission is fostering its support in preparing EU companies for a no deal scenario ("Hard Brexit").

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New FDA Guideline: Quality Aspects for Continuous Manufacturing

In February 2019, the FDA published a new draft guideline that addresses quality aspects of continuous pharmaceutical manufacturing. It covers topics related to development, process validation, marketing authorisation and routine production.

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Switzerland now also uses EudraGMDP

Switzerland has begun to enter information on GMP inspections into the EMA database.

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Is an Identity Test needed for the content of all Containers?

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

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WHO Recommends Re-Classification of Cannabis

After the legal situation for medical cannabis in Germany has already changed in 2017, the World Health Organization (WHO) has now proposed a global re-classification of the addictive potential of cannabis.

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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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