Handling of Changes to Medical Device Products for approved Combination Products

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.


Comprehensive Document about the Handling of OOE and OOT Results

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.


Deficiencies in Complaint and Recall Handling cause Warning Letter

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.


The Role of Visual Inspection in the Release of Parenterals

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?


FDA gets more Money

Overall, the US Food & Drug Administration (FDA) will have 491 million US$ above FY2017 budget according the new Agriculture Appropriations Bill.


FDA criticises missing Step 3 in the Process Validation Cycle

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).


Frequently asked: What does the Exposure Time of Disinfectants mean?

The question after the meaning and the handling of indicated exposure times of disinfectants is asked again and again.


ECA Visual Inspection Group Chairman appointed to EDQM Expert Group

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.


Qualification of Development Tools for Medical Devices - Guidance for Industry

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. 


Remarkably few Warning Letters to Medical Device Manufacturers in the first Half of Fiscal Year 2017

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.


Current FDA Publications regarding Medical Devices

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.


Guideline for Medicinal Products containing genetically modified Cells - EMA plans Revision

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.


Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells

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.


FDA Information about Human Cell and Tissue (HCT/P) related Inspections

The US Food & Drug Administration (FDA) published an overview about HCT/P inspections in the last five fiscal years.


EMA - New guide for healthcare professionals on biosimilar medicines

The European Medicines Agency (EMA), the European Commission and experts from the Member States issued a new Guide for Healthcare Professionals on Biosimilars.


FDA aligns Inspection and Regulatory Affairs Systems

The US Food & Drug Administration (FDA) plans to better coordinate regulatory affairs and field inspection activities to strengthen inspection and oversight of drug manufacturing worldwide.


FDA Warning Letter relating to the Use of an alternative microbiological Method

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.


Important Questions and Answers concerning the Audit Trail Review

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.


Warning Letter to Indian API Manufacturer: Equipment Deficiencies

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.


EMA´s Questions and Answers relating to Flexibility in Manufacturing Conditions

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".


GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information