GMP News

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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ICH´s Approach for Harmonization of Standards for Generic Drugs

The International Council for Harmonization (ICH) recently published a new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs".

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Current Activities of the GDP Association

The European GDP Association is quite active in supporting its members. What has been achieved in the past six months?

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EU-FDA MRA: Soon all States on board

The MRA with the USA was supplemented by two further countries: Poland and Slovenia. However some are still missing.

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Quality Metrics: More than an FDA Initiative

Quality Metrics can support both companies and regulators to guarantee a high quality performance and the continuity of quality product supply.

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WHO and IAEA - Draft Guideline on GMP for Radiopharmaceuticals

In January 2019, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) published a draft guideline dealing specifically with the GMP requirements for the manufacture of radiopharmaceuticals.

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Safety Features: Handling of Alerts

The safety feature provisions enetered into force - How to report a falsified pack?

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Current Questions and Answers on Data Integrity and Audit Trail Review

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.

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Brexit: OMCL Release Decisions still valid?

What happens if a certificate is issued before the withdrawal date but released after this date? New Q&As give a clear answer.

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EMA starts moving to Amsterdam

The European  Medicines Agency (EMA) has started with the relocation to the Netherlands and informs about contact details and continuation of the main activities.

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Hard Brexit: UK amends GMP and GDP Regulations

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

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EMA publishes comments on ICH Q12

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.

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Counterfeit Protection: 13th Version of Questions & Answers Paper published

The European Commission has published version 13 of  the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.

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EMA Guideline on Content, Management and Archiving of the TMF

The EMA published a new guideline on the content, management and archiving of the TMF clinical trial master file (paper and/or electronic).

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When does one speak of a "true" First in Human trial?

A new post, "Is it really a First in Human trial? Categorizing and assessing the risks correctly" has just been published on the MHRA Inspectorate blog.

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Clinical Trials if there is no Brexit Deal

To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.

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Non-Compliance at Chinese Heparin Manufacturer

A Non-Compliance Report due to several GMP violations has been issued to a Chinese heparin manufacturer after an inspection conducted by the Italian Health Authority. This report is now available on the EMA website for Non-Compliance Reports.

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Swissmedic Document on the Role of the RP in Contract Manufacturing

The Swiss authority Swissmedic has published a new auxiliary document for the so-called "RP Declaration".

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