GMP News - Quality Assurance

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.

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.

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

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

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.

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.

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