GMP NEWS 2011

IMB publishes Guide on GDP (wholesale distribution)

On 29 September 2011, the Irish Medicines Board (IMB) published the Guide on wholesaling of medicinal products for human use in Ireland. Here you will find more.

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New FDA and EMA Initiative allows mutual Recognition of Inspections

A new EMA/FDA initiative should enable the authorities in the European Economic Area (EEA) and the US to rely on the results of inspections performed in each other's territories. Read more.

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ICH Publishes Additional Q8/Q9/Q10 Points to Consider

At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics. Please find more about the new document which has been published on 6 December here.

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Anti-Counterfeiting Directive requires Import Certificate for the Import of APIs from Third Countries into the EU

Very soon third countries will only be allowed to export Active Pharmaceutical Ingredients (APIs) to the EU if an accompanying letter confirms that the exporting country fulfils certain requirements with regard to GMP regulations. This written statement is not necessary if the specific country was evaluated positively by the EU Commission before. Learn more about the first steps towards a new regulation which will become effective on 2 July 2013.

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Screening of Frequent Donors of Blood and Blood Components

The FDA published a Draft Guidance for Industry about the Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components. Read more.

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New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

The concept paper of the European Commission on safety features for medicinal products presents many questions to the stakeholders about the practical implementation. The deadline for comments is 27 April 2012. Read more here.

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Archiving of Chromatograms: FDA provides important Clarification

For the FDA, printed chromatograms alone do not satisfy GMP-compliant documentation of raw data. This statement has been issued in an FDA Question und Answer document. Read the complete News here.

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CEP Suspensions and Withdrawal due to GMP Deviations

The EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended and withdrawn a number of Certificate of Suitability (CEP) between September and November 2011. Please read more here.

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USP publishes First Ten Quality Standards in New Medicines Compendium

On November 28, 2011 the United States Pharmacopeial Convention (USP) published the first ten standards for the USP Medicines Compendium (MC). Click here to read more

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"Production Record Review" - The most frequently cited Paragraph in FDA Warning Letters

"Your firm has not thoroughly investigated the failure of a batch" - This is the most frequently cited criticism in the Warning Letters the US FDA issued to drug manufacturers in and outside the US in the Fiscal Year 2011. To get more information about the first results of the Warning Letters analysis that is annually published by Concept Heidelberg, please go here.

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Twelve Countries sign Medicrime Convention on Counterfeit Medicines

A further step has been made to fight against counterfeit medicine. Twelve countries have paved the way for the implementation of the Medicrime Convention by signing the first international treaty on October 28th. Please read more here.

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FDA wants to streamline the Classification of Blood and Plasma Recalls

To streamline the procedure for recall classifications and to save time and resources, FDA's CBER published the Direct Recall Classification Program for Blood and Plasma (DRC). More details can be found here.

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EMA publishes Concept Paper on Dedicated / Shared Facilities

In October, the European Medicines Agency published a new Concept Paper which has been developed by the Safety Working Group together with the GMP/GDP Inspectors Working Group. The document focuses on the establishment of an harmonised risk identification with toxicological data. Read more.

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WHO issues revised version of HVAC Guide

In July the World Health Organisation (WHO) issued a revision of its HVAC Guide. Read on here.

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New Concept paper on Annex 16 of the EU-GMP Guide

The European Medicines Agency (EMA) has published a Concept paper on revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release. Read more.

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FDA publishes Q8/Q9/Q10 Implementation Document

Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. Please read more about the document here.

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FDA Guideline on Anticounterfeiting Medicines

Following a draft which was issued in July 2009, the FDA developed and published the final Guideline on Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Forms in October 2011. Read more here.

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European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation

To find out what the European pharma industry thinks about the announced revision of the Process Validation Note for Guidance by the European Medicines Agency, the European Compliance Academy (ECA) together with Concept Heidelberg conducted a survey in September 2011. Read more here.

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New QP Declaration for managing Expiry Dates of IMPs

In the recently published EMA Reflection paper on IVR/IWR systems, an additional QP Declaration is introduced for managing expiry dates.  Read on here.

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MHRA announces Good Clinical Practice (GCP) Discussion Forum

The U.K. Medicines and Healthcare products Regulatory Agency MHRA has created a GCP Discussion Forum. Read more.

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