In irregular intervals, the ECA publishes overviews of the FDA's new guidances or draft guidances, webinars, general strategy papers and inspection results concerning medical devices. The following is a selection of medical device related publications of the past six months.
The FDA Center for Devices and Radiological Health (CDRH) has published its strategic goals on medical devices for 2013 in a document entitled "2013 Strategic Priorities." Read more about the recent FDA release of a location determination and further development of these strategies.
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.
TxCell has shut down their pilot site in Besançon due to some deviations found during an inspection of the French authority. Amongst others, several mould contaminations were found. Read more details about the report of the authority.
The US FDA has a new focus of their inspections: the review to the integrity of data. A recent Warning Letter from July 2015 shows again a clear focus on the issue of data integrity. Please find more information in the Current FDA Warning Letter regarding Data Integrity.
The performance qualification (PQ) or analogously to the validation, a fully automated inspection system in the 100% visual inspection, is carried out by comparing humans and machines. The intention is to show that machine inspections are not worse than human ones. But what number of test samples in PQ/validation of a fully automated (100%) visual inspection is required for a valid comparison?
Two new concept papers on the planned revision of the EMA/HMPC documents on the quality of herbal medicinal products and on the specifications of herbal medicinal products were published by HMPC on 1 June 2015. Please read on for further information on the HMPC Reflection Papers.
The authorities of the EU and of Switzerland signed a paper on the exchange of confidential information for a better protection of the public health. Find out more about the agreement of the EU and Swiss authorities.
New proposals for checking identities have been introduced in a USP article and published in the Pharmacopeial Forum, together with the planned chapter revision <191>. In future, the checks will be much more flexible. Find out more about the planned Update of the Identity Check in the U.S. Pharmacopoeia.
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.
In July 2015, the second MHRA blog on the theme of data integrity went live. This time, the focus is on designing systems properly. The ALCOA principles are considered to be very helpful. Read more about the MHRA Good Manufacturing Practice (GMP) Data Integrity blog part 2.
An Addendum to the ICH M7 Guideline was recently published. Please find more details about the new Addendum, e.g. examples to calculate acceptable intakes for specific compounds known to be carcinogenic which are described in this document.
The list of countries from which the shipment of API batches to Europe is possible without "Written Confirmation" has recently been expanded to Israel and Brazil. Learn more about the regulation for API exports to the EU important for third countries.
Within one week the Italian authority published three reports on inspections in API manufacturing sites in the Eudra GMDP database. Read more about what GMP deficiencies were found in these manufacturing sites and what consequences it will have for the relevant companies.
Use of the CTD format is mandatory for the registration of traditional herbal medicinal products. Now, the EMA wants to update the HMPC Guideline in this respect. In future, a mock-up will also be part of the Guideline. Read more about the Revision of the EMA/HMPC Guideline.