In a recent news you could read about a question-and-answer document from the EMA, describing certain issues concerning the handling of changes after approval ("variations"). This document has been updated again. The topic of changes to medical devices after the approval of "combination products" has now been added.
How are OOE and OOT results in the pharmaceutical industry to be recorded and assessed nowadays? To answer this question, the ECA Quality Control Working Group and representatives from authorities and industry compiled a guidance document about the handling of Out-of-Expectation (OOE) and Out-of-Trend (OOT) results. Find out more about the 70 page OOS/OOT guidance document.
Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. Failure to fully investigate the scope and root causes of reported complaints and to take appropriate action regarding recalls of defective products were the main points of criticism. Find out more about the deficiencies in complaint and recall handling that resulted in a Warning Letter.
According to the requirements of pharmacopoeias (e.g. EU or US), batches of sterile injectables must be 100% visually checked for defects. This test must be validated; because of its probabilistic nature, however, it is not 100% free from errors. How is this to be handled in the course of releasing batches?
Since publishing the FDA Process Validation Guidance in 2011, the FDA regards process validation as a three-step lifecycle. In a recent Warning Letter, the FDA criticises the absence of step 3 (Continued Process Verification).
Dr Tobias Posset, Head of Production Support at Roche Diagnostics in Mannheim, Germany and chairman of the ECA Visual Inspection Group, was recently appointed into expert group 12 of the EDQM (European Directorate for the Quality of Medicines & Health Care). Amongst other things, this expert group develops recommendations for the revision of monographs concerning visual inspection. Learn more about Dr Posset's appointment to the EDQM Expert Group.
The topic of development has been playing an important role for the FDA, not only in the pharmaceutical sector, but also with regard to medical devices for quite some time. An FDA draft guidance document on the qualification of development tools from 2013 has now been finalized.
The ECA evaluates deficiencies regarding medical devices in FDA Warning Letters on a regular basis. Remarkable is the low number of Warning Letters to medical devices manufacturers in the first half of fiscal year 2017.
In irregular intervals, the ECA publishes overviews about new guidelines or guideline drafts, webinars, general strategy papers and about FDA inspection results regarding medical devices. Find out what the FDA issued recently with regard to medical devices.
The European Medicines Agency (EMA) proposes a revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells and published an corresponding concept paper incuding the current scientific developments.
The US FDA published Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient.
The FDA issued a Warning Letter objecting to inadequate microbiological testing and product contamination with Burkholderia Cepacia and other microorganisms and following adverse events. Find out more abou the FDA Warning Letter.
The webinar "Audit Trail Review" took place in February 2017. Its aim was to address the main elements of data integrity and audit trail reviews. Participants have sent more than 50 questions regarding the webinar which the speaker, Dr Wolfgang Schumacher, has partly answered in writing. Learn more about the Webinar Audit Trail Review and about the corresponding questions asked.
Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. The state of the manufacturing equipment and the missing validation of a tableting process were the main points of criticism. Find out more about the Warning Letter due to equipment deficiencies.
The EMA recently published a Questions and Answers document in relation to presentation of process information in the marketing authorization dossier and management of changes to an approved design space. Read more about the document on "Improving the understanding of NORs, PARs, DSp and normal variability of process parameters".