GMP NEWS 2011

FDA announces New Worldwide Strategy on GMP Supervision and Importation

The manufacture of drugs, food, and medical devices is strongly fragmented and largely globalised. Because of this fact, there is an increase in the number of monitored manufacturing sites and imported products. This is a current issue in the USA. To meet new challenges, the FDA reacted with a strategy report. Read more here about the FDA planned change in strategy.

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Audio Presentation of ICH Q8, Q9 and Q10 now available

Recordings of some presentations have been compiled during a meeting of the International Conference on Harmonisation. These have now been posted online. Read more here.

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New ICH Q11 Guideline published

On June 16, 2011 the ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) was published as a Step 3 document. Read more here.

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Why did FDA change their Guideline on Process Validation?

The 4th European GMP Conference took place in Heidelberg on 19/20 May 2011. During the Conference, Grace McNally, co-author of the new FDA Process Validation Guidance presented the reasons for the revision of this Guidance. Read more here.

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FDA creates "Super Office" for better GMP Monitoring and Fight against Counterfeit Medicines

With the new "Super Office", the US FDA restructured the Office of Compliance - the most important Office in the field of GMP. Read more here.

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New EMA Concept Paper on Process Validation of Biotechnology derived active Substances

On 19 May 2011, the EMA published a "Concept Paper on the need for a guideline on process validation of medicinal products containing biotechnology derived proteins of active substances". For the EMA, it was necessary to develop a Guideline, ... read on here.

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How compliant is your supplier? FDA establishes new Online Inspection Database

On May 26, 2011 the U.S. Food and Drug Administration announced a new web portal on its inspection activities. A key element of this new web portal is a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification. Here you will find more.

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Modernisation of USP Monographs

The list of monographs in need of revision was updated on 26 April 2011. Read here which monographs the USP plans to modernise.

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In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens

On 23 May the US Health and Human Services Department published a notice in the Federal Register which includes nomination of In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens; Data Request for Substances Evaluated by these Test Methods. More details can be found here.

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The Council of the European Union adopts Falsified Medicines Directive! Major challenges for Users and Producers of APIs and pharmaceutical Excipients to be expected

The Falsified Medicines Directive has been adopted by the Council of the European Union on 27 May 2011. It is now about to be published in the Official Journal of the European Union within the next days. It contains substantial changes with respect to GMPs for APIs and pharmaceutical excipients. Please read here more about these new challenges for the API and pharmaceutical industry.

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EMA Report on Clinical Trials outside the EU

The European Medicines Agency (EMA) published a report from a workshop on ethics and GCP in clinical trials outside the European Union. Read more.

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The 4th European GMP Conference a great Success - Read more about major GMP Developments

From May 20-21, 2011 the 4th European GMP Conference was held in Heidelberg. The Conference attracted delegates from 25 different countries. The conference was booked up! Read more about the highlights.

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FDA publishes annual Fatalities Report regarding Blood Collection and Transfusion

The US FDA published their fatalities report of blood collection and transfusion for the fiscal year 2010. More details about the report and the comparison with former reports can be found here.

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The Challenges of Ensuring Laboratory Data Integrity

The integrity of laboratory data generated in analytical labs needs to be ensured for paper systems, for paper and  electronic systems (hybrid), as well as for electronic systems. The problem is that "raw data" has not been defined in the new EU GMP Chapter 4. Please find in Dr. Bob McDowall's article how the definition of "raw data" in the GLP regulations can help.  

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Suspension and Withdrawal of CEPs by EDQM

The EDQM announced on May 17, 2011 the availability of the revised policy document 'Suspension or Withdrawal of a Certificate of Suitability'. The EDQM also annouced information about new CEP suspensions and withdrawals due to failures to comply with the GMP requirements. Read more here.

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New Annex 14: Consequences for QPs

The EU has revised Annex 14 of the EU GMP Guide, defining requirements for drugs derived from human blood or plasma. In this context, requirements for the respective Qualified Persons have been updated. Read more.

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FDA asks how to improve existing Regulations

The US Food & Drug Administration (FDA) announced that the agency is formally asking for submissions on how to improve existing regulations. Read more.

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EMA: Monitoring of Products originating from Japan for the Possibility of Radioactivity

EMA is working with its European and international regulatory partners to monitor and evaluate the possible risk of radioactive contamination of medicines manufactured in Japan. Read more.

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Quality by Design for pharmaceutical Excipients - IPEC publishes new Checklists and Q&A Document

Three new documents published by the IPEC provide useful information for suppliers and users of APIs on Quality by Design at early stages of development.  Read more here.

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EP 2.6.31. Microbiological Examination of herbal medicinal Products for oral Use under Revision

The EDQM announced the revision of the monograph 2.6.31. "Microbiological examination of herbal medicinal products for oral use" which specifies inspections for herbal drugs with particular specifications for Escherichia coli, salmonella and gram-negative bacteria with bile salt tolerance. More details can be found here.

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