GMP NEWS 2011

Validation on Rank 3 in the FDA Warning Letter Statistic 2010 regarding Medical Devices

Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. In the following, you will find a ranking based on the evolution of the Top 5 deviations in the FDA Warning Letters (regarding Medica Devices) issued between the years 2002 and 2010. On place 1 is … Read more here.

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Batch Record Review as GMP Deviation cited in FDA Warning Letters

As indicated by ECA's Warning Letter Report, Production Record Review deviations are (again) the most frequent GMP observations made by the FDA. Read more.

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EMA adjusts Fees for Marketing Authorisation Applications

From 1 April 2011 the EMA will charge new fees for its services in relation with marketing authorisations of medicinal products. Yet, fee reductions will be applied for marketing authorisations of orphan drugs, when specific criteria are met. Read more here.

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ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components

The lifecycle management section of the newest working draft of ICH's Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions. Read one here.

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Concept Paper on the Revision of the GCP Directive published

The European Commission has published a Concept Paper on the revision of the GCP Directive 2001/20/EC. Both the contents of the directive and the transposition into national law now might be revised. Read more.

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IMPD: EMA provides further Clarification for Quality of IMPs

The European Medicines Agency EMA has published a set of new Questions and Answers regarding the quality of Investigational Medicinal Products (IMPs). Read more.

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Specific WHO Requirements for Dissolution Studies to Support Biowaivers

The requirements on dissolution testing and the main focuses of an inspection are at the core of the WHO document "Points to Consider for Inspections of Biowaiver Data". You can read more about this new WHO-Dokument here. 

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Revision or Renewal of CEPs: Requirements for Notifications to the EDQM

The EDQM has to deal with an increasing number of deficiencies in the notifications regarding revisions or renewals of CEPs which makes the procedure inefficient and which could be easiliy avoided. Here you can read more about the most common deficiencies found in the documents submitted to the EDQM.

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EU-GMP Guide: New Introduction with Clarification of Status of Part III

As mentioned in a previous news, ICH Q9 and ICH Q10 will be adopted as Part III of the EU GMP Guide. In this regard, the EU Commission has revised the Introduction of the EU GMP Guide and clarified he status of the new Part III. Read more.

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"Q3D: Impurities: Guideline for Metal Impurities" - a new ICH Concept Paper

The control of residual solvents and organic impurities in drugs and APIs is "globally" regulated in respective ICH guidelines (resp. for the economic areas Europe, USA and Japan). For metal impurities there is no comparable harmonised document available, though. The ICH initiated the development of a new guideline in order to close this gap. Read more here.

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Guideline on Testing for the Detection of Mycoplasma Contamination of veterinary medicinal Products

The CVMP of the European Medicines Agency published the draft of VICH GL34: Guideline on testing for the detection of mycoplasma contamination for further consultation. More about the guideline can be found here.

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New EMA/HMPC Reflection Paper on Stability of Herbal Medicinal Products

The EMA/HMPC/3626/2009 Reflection Paper depicts the need for specific guidelines on Stability for herbal and traditional herbal medicinal products and presents the solution which is agreed on. Click here  to get more information. 

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DMA Document on Expectations for Audits of API Manufacturers

The Danish Medicines Agency (DMA) has published a document entitled: The Danish Medicines Agency's expectations for audits of API manufacturers. The DMA defined a number of expectations which need to be fulfilled if the QP delegates the task to a third party.  Read more here.

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Updated Q&A Document on the Submission of Variations published

The CMDh updates irregularly a Q&A document about the difficulties concerning the submission of variations applications and the classification of changes according to the new "Variations Regulation" (EC) 1234/2008. An updated Q&A document has been recently published. Read more here

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EDQM develops Live Demo for a Track & Trace System

The EDQM, which works on a Europe-wide Track & Trace system as part of its anti-counterfeiting strategy, has announced the creation of a live demo for Phase 2 of its project. Read more.

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EMA publishes final ‘Road map to 2015’

The European Medicines Agency has published its final 'Road map to 2015', setting out EMA's role as a public-health agency. Read more.

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New Pharmacovigilance Legislation adopted

Following the adoption by the Council and the European Parliament, a new Regulation and a new directive on pharmacovigilance were published in the Official Journal of the EU. Read more.

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Discussions about Material Certificates

The question around the material certificates needed for metallic products has long existed. Still, this topic is continuously being discussed. Read more. 

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EMA/HMPC Reflection Paper on Extracts Purification

An EMA/HMPC Reflection Paper on the Level of Purification of Herbal Preparations to be considered as such has been published. Go here for more information. 

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USP <85>Bacterial Endotoxin Test - proposed interim Revision Announcement

The USP proposed an interim revision of chapter <85> "Bacterial Endotoxin Test" based on a recommendation of the FDA and additions to the harmonised texts. Find out more here.

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