GMP News - Quality Assurance

26.10.11

FDA defines 25 SOP provisions required by CFR

The latest edition of the Federal Register shows a very good summary of SOPs required by 21 CFR Part 211. Read more.

more

26.10.11

FDA publishes List of Guidance Documents for Medical Devices

In early October the FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development  in the fiscal year 2012 (October 2011- September 2012). Read more here.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications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

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics