GMP News - APIs and Excipients

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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31.07.13

Written Confirmation: A Questions & Answer Document of the Danish Authority provides further Clarifications

The regulation regarding the imports of APIs into the EU which must be accompanied by a Written Confirmation has been effective since 2 July 2013 and keeps on raising new specific questions. The DHMA (Danish Health and Medicines Authority) has recently published a Questions & Answers document. Read more here.

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24.07.13

How do I apply for a CEP? An updated guideline of the EDQM provides information

In an updated guideline for CEP applicants, the EDQM describes in what form they have to submit the documents to apply for a certificate of suitability. Learn more about this guideline and the application procedure here.

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17.07.13

Risk-based Approach to APIs Consignments without Written Confirmation

API consignments without Written Confirmation which are trapped on the EU external borders and held under quarantine - how to handle this situation? A guideline of the HMA provides the answer. Read more here.

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17.07.13

CEPs are becoming more transparent!

Starting on 15 July 2013 there will be new regulations applying with regard to the information content of Certificates of Suitability (CEPs). Learn more about what exactly will change.

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19.06.13

Guideline on the European Drug Master File Procedure updated

The EMA Guideline on the European Drug Master File (ASMF) Procedure was updated again. Learn more about the new requirements API manufacturers and applicants will be facing.

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19.06.13

Written Confirmation: Japan on the List of "Third Countries"

Japan is the next API exporting country on the list of countries which don't need to issue "written confirmations". Read more here.

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