GMP News - APIs and Excipients

30.10.13

New Q&A Document of the CMDh gives Answers to Essential Questions on the ASMF Procedure

When will the new single EU numbering system for ASMFs be obligatory? Can an ASMF holder have more than one ASMF for one active substance? Those questions and other ones have been answered in a new Q&A document on the ASMF procedure published by the CMDh at the end of September. Read more here.

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02.10.13

FDA publishes current list of Drug Master Files (Type II)

Since the introduction of the Generic Drug User Fee Act (GDUFA) all Drug Master File (DMF) holders are required to pay a fee and the DMFs have to undergo a completeness assessment. The FDA has now published a list with all DMFs which meet these criteria. Read more.

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02.10.13

New MHRA's Webpage on the Falsified Medicines Directive

The United Kingdom has established a webpage about the Directive on the prevention from falsified medicines ("Falsified Medicines Directive"). Read more here about the information contained on this page and learn why it is important to visit it.

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26.09.13

European Pharmacopoeia Chapter 5.20 "Metal Catalysts or Metal Reagent Residues": Implementation Delayed Until Further Notice!

Ph. Eur. Chapter 5.20 on metallic impurities won't become legally binding until further notice. Read more about the background and the connection with the new ICH Q3D Guideline.

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18.09.13

EMA publishes revised dossier-submission requirements for active-substance master files

The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. Go here to read more.

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18.09.13

WHO publishes revised draft on GTDP for pharmaceutical starting material

The WHO has published a proposal to revise the Good Trade and Distribuiton Practices for Pharmaceutical Starting Materials. Read more.

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11.09.13

EXCiPACT - Pilot Phase Successfully Completed!

After a successful completed pilot phase, the ExcipactTM scheme will further expand as quality standard for GMP and GDP audits of manufacturers of pharmaceutical excipients. Read more here about the worldwide recognised audit scheme.

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11.09.13

New FDA Fees for Drug Master Files published

The US FDA has published the new fees for 2014. Please read more about the Drug Master File Fee and the API Facility Fee in our GMP News.

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04.09.13

USP Elemental Impurities Implementation Advisory Group - Meeting Summary

The newly formed USP Elemental Impurites Implementation Advisory Group considers issues experienced by manufacturers of products especially affected by the elemental impurities standards. Read more about the output of the Group's last meeting.

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28.08.13

Changes in the EDQM CEP Database

The EDQM maintains a database that contains the relevant information about the Certificates of Suitability (CEP). Read more about the changes in the CEP database.

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13.08.13

Updated Procedure for the Renewal and Revision of CEPs!

As of 1st September 2013, an updated procedure for the renewal and revision of CEPs will apply. By the end of July, the EDQM had already published the respective revised Guidelines and application forms. Read more here about the coming expectations for CEP holders.

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13.08.13

New EMA Guideline on Starting Materials from Biological Medicinal Products

A new EMA Guideline clarifies the most important questions about the definition of starting materials and intermediates of biological medicinal products as well as the quality documentation of the marketing authorisation dossier. More details here.

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06.08.13

Draft Guideline ICH Q3D for Elemental Impurities published!

The ICH Q3D Guideline on Elemental Impurities has just been published. This Guideline will have a major impact on both the pharmaceutical and the API industry and companies now have  to make efforts to be prepared for the new provisions of the guideline. More details here.

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06.08.13

Denying, Delaying, And Refusing: How to Fail a FDA Inspection

The FDA has published a new Draft Guidance on "Limiting an inspection" for comment. The document provides a detailed presentation of behaviours during a FDA inspection which may be seen as obstruction by the FDA inspectors. More details here.

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06.08.13

CDSCO publishes more than 200 Written Confirmations for APIs from India

Written Confirmations for pharmaceutical APIs from India to be exported to the EU have been made publicly available by the CDSCO. Read more here.

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