GMP News - Quality Assurance

20.10.11

FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

The US Food and Drug Administration (FDA) has issued a report in which it proposes to make Compliance and Enforcement Information more accessible and user-friendly. The proposals are part of FDA's current efforts to make its operation and decision making more transparent. Read more.

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05.10.11

EMA Reflection Paper provides Concrete Information about Risk based Quality Management

The "Reflection paper on risk based quality management in clinical trials" recently published by the EMA contains a table (Annex 1) which presents the points to consider for the risk identification, examples of how to control them and eventually mitigation and/or acceptance solutions. This gives interesting insights into EMA's specific positions about risk control. Read more here.

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21.09.11

FDA criticises SOP Training in pharmaceutical Companies

Reviewing FDA's warning letters of the last fiscal year reveals that management and training of Standard Operating Procedures (SOPs) is still a hot topic. Read more.

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07.09.11

European QP Association forms Expert Panels

After the first five successful years of its existence, the European Qualified Person Association (EQPA) decided to develop a new structure and to integrate more colleagues into its activities. Read more.

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FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications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