GMP News - Quality Assurance

As a result of the PIP scandal the regulatory basis for medical devices will be revised. One of the planned changes was already covered in a previous news: The QP for medical devices. The requirements for this person were listed in § 13 of the first regulation draft. Now there is a second draft that also comprises changes for this Medical Device Manufacturers' QP.

The Food and Drug Administration (FDA) regularly issues drafts of their reveised guidances. What most people do not know is that anyone may comment on these drafts. Find out how you can comment FDA regulations.

A new final rule from the US FDA requires drug manufacturers to notify the agency of discontinuance or an interruption in manufacturing six months in advance.

The HMA (Heads of Medicines Agencies) and the EMA (European Medicines Agency) have issued a high level EU document in order to plan the strategy of the EU regulators for the upcoming 5 years. On 27 March 2015 a consultation draft entitled "EU Medicines Agencies Network Strategy to 2020" has been published. Please read more about the strategy plan of EMA and HMA.

The implementation of the Guideline ICH Q3D provides a great challenge for both drug manufacturers and active substances producers. Here, you can see the practical advice that the "Industry Coalition" makes available for the Control of Elemental Impurities.

A new Strategy Paper has been issued by the European Agencies. Read more about the Network Strategy to 2020.

Current scientific data on the occurance and risk of Posttransfusion Purpura (PTP) were published on  the Advancing Regulatory Sciences site of the US Food and Drug Administration. Read more about the Data on Posttransfusion Purpura (PTP).