GMP News - Quality Assurance

31.08.11

FDA Courses and Tests now available online

The organisation and the regulations of the US Food & Drug Administration (FDA) are frequently considered hard to comprehend. With regard to medical devices the CDRH runs a quite detailed website. Read more.

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24.08.11

EU GMP Guide: New Requirements added for Batch Certification

In Part III of the EU GMP Guide, a document on internationally harmonised requirements for batch certification has been added. Read more.

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24.08.11

FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications

End of July, the FDA published a draft on the documentation of medical device modifications. Read more about the 26 pages document here.

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24.08.11

New WHO guidance for Storage and Transportation

WHO has published a model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products. Read more.

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10.08.11

EU Product Quality Review now also part of WHO GMP main Principles

The WHO has incorparated a new section on "Product Quality Review" in its GMP Main Principles for Pharmaceutical Products. Read more.

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10.08.11

FDA publishes SOP for "Notice to Industry" Letters for the Medical Devices Industry

The FDA Center for Devices and Radiological Health (CDRH) has published a SOP to describe how it will inform Medical Devices manufacturers about new or modified requirements/expectations by use of "Notices to Industry" Letters in the future. Read more.

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03.08.11

New FDA Draft Guidance regarding Design Development of Medical Devices

Until 19 September 2011 you have the possibility to comment and maybe influence the new FDA Draft Guidance regarding Design Controls of Medical Devices. Read more here.

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20.07.11

New: ICH Guideline for ICH Q8, Q9 and Q10 implementation

There is still a lot of uncertainty about how the three guidelines should be used in combination. A new Points to Consider document is intended to provide clarification. Please find more information here.

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06.07.11

New Guideline on EMA Certificates of Medicinal Products

The Regulatory and Procedural Guideline of the European Medicines Agency (EMA) on Certificates of Medicinal products - Instructions on how to fill the Application Form has been adopted. Read more.

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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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