GMP News - Quality Assurance

06.07.11

Contract Manufacturers and Contract Laboratories do no longer need to be pre-approved by DMA

The Danish Medicines Agency (DMA) recently changed its practice to pre-approve contract manufacturers and contract laboratories acceptors. Read more.

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06.07.11

FDA's membership of PIC/S - why it is important

On 1 January 2011, FDA joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) . Now, Dr Margaret A. Hamburg, Commissioner of the FDA, gave an interesting talk about the membership and its benefits. Read more.

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29.06.11

FDA plans on publishing further GMP and CMC Guidances for Combination Products

A drug and a device, a drug and a biological, a biological and a device, or maybe even all three can create a combination product. But what regulation is applicable for those products? Which new Guidance documents will be published soon? Please read more about this development in a very detailed article provided by the IPQ - one of the most important Journals in the GMP and regulatory environment. Read on here.

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25.05.11

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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18.05.11

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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18.05.11

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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11.05.11

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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11.05.11

FDA's Strategic Priorities 2011 - 2015 now available

The U.S. FDA released the final version of a strategic priorities document outlining the goals that will guide the agency through 2015. Read more.

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04.05.11

CAPA among the most frequent GMP Deviations cited in FDA Warning Letters

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

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28.04.11

Nuclear Load of pharmaceutical Products from Japan

Both ECA and Concept Heidelberg increasingly receive requests on whether a pharmaceutical manufacturer has to check substances and medicinal products from Japan for nuclear loads. Read more about the current situation.

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28.04.11

Revision of Chapter 8 of the EC guide to GMP

EMA's GMDP Inspectors Working Group has agreed on a concept paper on revising chapter 8 'Complaints and Product Recall' of the EC guide. Chapter 8 should introduce Quality Risk Management principles and appropriate root cause analysis work when investigating quality defects/complaints for both marketed products and  IMPs. Read on here.

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13.04.11

New answers published about Variations: EMA's updated "Post-Authorisation" Guideline

The compilation of EMA's Questions & Answers on Variations has been recently updated. Additionally, a Procedural Guideline has been published. Read more about the new developments here.

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13.04.11

Quality IWG Training Material on ICH Q8, Q9 and Q10

The Quality Implementation Working Group has developed a consolidated training package on ICH Q8, Q9 and Q10 that is now available on the ICH website. Read more.

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06.04.11

Annual Product Review (APR) as GMP Deviation in FDA Warning Letters

Reviewing FDA's Warning Letters of the last fiscal year reveals that the Annual Product Review (APR) is still a hot topic. The main reasons can be found in failing timely completion and in inadequate processes. Read more.

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25.03.11

Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis)

At the end of last year, drafts about the changes of Chapter 7 (Contract Manufacture and Analysis) and Chapter 5 (Production) of the EU GMP Guide have been published. With regard of these changes, the European Compliance Academy (ECA) conducted a survey. The results were sent to the EMA too and - maybe - influence the final versions. Read more about the results of the survey here

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