GMP News

New EMA Guidance to prevent and mitigate Medicine Shortages

The EMA has published a Guidance for Industry on "Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact". It provides ten recommendations for various stakeholders.

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FDA Paper on Artificial Intelligence in the Manufacture of Medicines

The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.

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Annual Report and updated Work Plan of the GMDP Inspectors Working Group - What's going on in GDP?

The European Medicines Agency (EMA) has published the annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022. An updated work plan 2021-2023 has also been issued.

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Summary of the MHRA Good Distribution Practice Symposium 2023

Just recently, you could read about the Good Manufacturing and Distribution Practice Symposia 2023, organized by the Medicines and Healthcare products Regulatory Agency (MHRA) on 21 and 22 February 2023. A summary of the GDP part was now published on the MHRA Inspectorate blog.

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GDP Non-Compliance Report: No authorized Storage Facilities and Services of a Qualified Person not ensured

After the competent authority of Czechia (State Institute for Drug Control) had just recently added four GDP Non-Compliance Reports to the EudraGMDP database, another one was added at the end of April 2023.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 2

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 2 here.

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Medical Cannabis in Germany: From the BtMG to the Cannabis Act?

According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG). What changes may result?

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Draft of USP Chapter <711> Dissolution (PDG harmonized document) Published for Comments

In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The new draft represents the Pharmacopeial Discussion Group (PDG) harmonized document.

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Revision of USP Chapters <782> Vibrational Circular Dichroism Spectroscopy and <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice

In the Pharmacopeial Forum, PF 49(3), proposals of revised USP General Chapters <782> Vibrational Circular Dichroism Spectroscopy and <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice were published for comments.

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Dead Leg in Pharmaceutical Water System leads to Warning Letter

Due to deficiencies found in an FDA inspection, a US pharmaceutical manufacturer has now received a Warning Letter. Among other things, a dead leg in the pharmaceutical water system is listed as a deficiency.

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Cloud Computing: Is a check list for the assessment of a Cloud Service Provider sufficient?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 12: Will it be sufficient to send a check list for the assessment of the CSP - for instance Amazon and Microsoft?

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New EMA Guidelines and Revisions in GMP Area

EMA has published a new version of the "3-year work plan for the Quality domain". This also includes partly renewed timeframes for the revision of GMP specifications.

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USP Publishes Draft on Quality Requirements for Cannabis

The USP previously announced to elaborate a chapter on quality considerations for Cannabis. Now the draft chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research has been published in PF 49.3. Comments can be sent to the USP until end of July.

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USP Draft for Dronabinol Capsules

The USP published the draft monograph for Dronabinol Capsules in PF 49.3. Comments can be sent to the USP until end of July.

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Herbal Medicines for Children

The EMA has published on its website an updated overview with recommendations for the use of herbal medicinal products (HMPs) in children.

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EMA IRIS Guides updated again

In February and April 2023, the "IRIS guide to registration and RPIs" was updated again and is now valid as version 2.13. Like the "IRIS guide for applicants" and "IRIS guide to parallel distribution applicants", the latest versions of this document are available on the EMA website.

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EMA updates Timelines of eAFs for Variations for Medicinal Products for Human Use

In future, submissions of variation notifications for medicinal products for human use are to be made exclusively via the electronic application forms (eAFs). The timelines for the full implementation of these systems have now been updated again and are listed on the EMA website in the PLM Portal (Product Lifecycle Management Portal).

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CMDh: Update of Q&As on Renewals

The CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) updated the Q&A document on "Renewals" in March 2023 and published it on the HMA (Heads of Medicines Agencies) website in the CMDh - Questions & Answers section in April.

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EDQM: Updates on CEP 2.0

As part of the implementation of the new "CEP 2.0", the EDQM has now provided further information on its website.  

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Revised USP General Chapter <781> Optical Rotation published for Comments

In the Pharmacopeial Forum, PF 49(3), a proposal of a slightly revised USP General Chapter <781> Optical Rotation has been published for comments.

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Switzerland: New Declaration of the Responsible Person for foreign Manufacturers

Swissmedic has specified the conditions for the submission of an audit report by the Responsible Person as proof of GMP compliance of foreign manufacturers.

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FDA Warning Letter: Root Cause of Benzene Contamination not unterstood

The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. An OTC manufacturer received information indicating that the finished drug products produced with isobutane propellants were contaminated with benzene. The company's own analyses as well as results of the FDA laboratory testing confirmed the presence of this impurity. The company failed to perform adequate investigations and so far, the root cause of the benzene contamination is not understood.

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Cloud Computing: Audit / Remote audit of a Cloud Service Provider

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 11: How many days must be planned for the audit of a CSP? Is it also possible to carry out a remote audit?

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Do pharmaceutical Water Systems need a sterile Ventilating Filter?

Pharmaceutical water systems (PW and WFI) require a ventilating filter on the storage tank. It prevents dirty ambient air from being sucked into the system when water is withdrawn from the tank. This is often referred to as a sterile filter. However, there are numerous requirements for "real" sterile filtration according to the current EU GMP Annex 1. But is sterile filtration even necessary for this application?

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EDQM: CEP Report

In March 2023, the EDQM once more prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has now published it in the newsroom of the EDQM website.

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