GMP NEWS 2012

EU: new Delegated Act on Shipments of Medicinal Products through EU

The  European Commission has published a draft Delegated Act concerning a new requirement of the Falsified Medicines Directive under which medicinal products being shipped through the EU. Read more.

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The new EU Good Distribution Practices (GDP) Guideline - What will happen next?

In order to change the "old" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version on 15 July 2011. The EU Commission received a large number of comments from stakeholders. But what are the next steps? Please find more in our GMP News.

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ISPE Mapping Document explains Relationship between different Qualification Guides

The ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&G) has been available since 2001. Now, an ISPE mapping document explains the relationship between the ISPE Baseline Guide Volume 5 and the new ISPE Guide "Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment" (FSE Guide). The mapping document also presents an ISPE Guide (Applied Risk Management Guide) which has the function of a "bridge" between these two documents. Read this news to get an overview of this "Mapping-Document for ISPE Specification and Verification Guides" that explains the relationship of different ISPE Guides with regard to qualification.

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The new EU GMP Guide Annex 2 - a brief Content Summary

On 31 January 2013 the new Annex 2 of the EU GMP Guide becomes effective. In comparison to the version valid so far the new version has clearly increased in terms of volume and content. This is also due to the fact that it now takes into consideration the development of new types of biological medicines. Read more.

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Extension of Directive 2003/94/EC to GMP for APIs - EU Commission publishes Comments on Concept Paper

The intention of the EU Commission to integrate GMP regulations for APIs into the existing Directive 2003/94/EC via a delegated act faces rejection from companies and industry associations. Their comments on the respective concept paper from the EU Commission have been recently published. Read more here.

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Dissolution Testing of new and special Dosage Forms - Updated FIP/AAPS Document

Due to the rapid evolution of new practices and techniques for dissolution/drug release testing, FIP decided to revise the previous position paper from 2003. Get further information.

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EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations

The European Medicines Agency has today agreed on a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. Read more.

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Actual GMP Deficiencies concerning Validation/Qualification/Calibration as seen by the MHRA

In our news from 4 July 2012 we reported on a publication on the results of inspections carried out by the MHRA (Medicines and Healthcare Products Regulatory Agency, MHRA). It is worthwhile to take a look at this publication also beyond the actual top ten list of deficiencies, since there are relatively few publications on GMP deficiencies by European authorities. The following observations focus on the topics process validation/equipment qualification/calibration.

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Japanese Requirements on Computerised Systems

Japaneses GMP requirements are defined by the "Pharmaceuticals and Medical Devices Agency - PMDA". Now, a tentative translation of the requirements on Computerised systems into English is available. Read more.

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cGMP: SOP Management and Training criticised by FDA

Reviewing FDA's warning letters of the last fiscal year reveals that incompleteness, management and training of Standard Operating Procedures (SOPs) is still a hot topic. Read more.

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Finally published: new EU GMP Chapter 7 on Outsourced Activities

Chapter 7 of the EU GMP Guide "Contract Manufacture and Analysis" has also been revised, and the European Commission recently issued the final version. Read more.

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Finally published: new EU GMP Chapter 1 with comprehensive Changes

The European Commission has published the final version of the revised Chapter 1 of the EU GMP Guide, which will now be called "Pharmaceutical Quality System". It includes comprehensive changes. Read more.

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GMP Guideline Annex 2 revised

The Europen Commission announced the revised Annex 2 of the EU GMP Guide as one of the major developments of the GMP regulations. Read mor here.

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USP Standard for Dissolution Testing withdrawn

USP has withdrawn a standard for the Apparatus 3 Performance Verification Test for dissolution testing as of February 2012. Get more information, also about the background - in this news.

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ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA

The FDA has put into effect the ICH document with points to consider covering topics relevant to ICH Q8, Q9 and Q 10 in July 2012. This guideline is intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment, and inspection related to QbD-applications filed for marketing authorisations. Get the complete news.

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FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)

In July 2012, the FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical devices (Unique Device Identification System, UDI system). The Congress had already enacted a law in 2007. A draft is now available.

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Chinese SFDA issues new Regulation on a strengthened Supervision of Pharmaceutical Excipients' Manufacturers

The new regulation of the Chinese State Food and Drug Administration defines a strengthened supervision of the manufacture of pharmaceutical excipients. Read here who will be affected by these new provisions.

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IEC 60601-1 valid in 3rd Version since June 2012 - Risk Management playing important Role

After a long transitional period the Norm IEC 60601-1 with regard to security requirements and ergonomical demands for medical devices has become effective as Version 3 on 1 June 2012. Specifically interesting in this new version is the topic risk management. Read more.

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Will there be a Registration Obligation for critical Medical Devices?

Following the PIP scandal the EU currently deals more intensively with the planned revision of medical devices regulation. In a resolution the European Parliament has now proposed various measures to eliminate the "system's malfunctions on a European and a national level". Read on.

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New Guide for Manufacturers of Stand Alone Software

On June 12, 2012 the Medical Products Agency (Swedish Authority) published an introduction to the so called MEDDEV 2.1/6 Guidelines. Read more.

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