A Canadian manufacturer of medicinal products received an FDA Warning Letter due to the fact that not all batches of manufactured drug products and the active materials used therein had been tested for compliance with the specifications before their release. Get information on the Cellex-C FDA Warning Letter.
It's a well-known fact that the US FDA publishes GMP deficiencies in their Warning Letters. For some years now, there has also been a European portal, where non-compliance results are published. In August 2017, an Upper Bavarian supervisory agency has issued such a statement of non-compliance with GMP to an Indian manufacturer of medicinal products. Which deficiencies were found?
The European Commission has published their long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU GMP Guideline.
The Detailed Commission Guidelines on GMP for IMPs have now been published as final in Annex 13 in EudraLex Volume 4.
With the resignation of Richard M Bonner as Chairman of the Advisory Board of both the ECA Foundation and the European QP Association (EQPA) the organsation has announced changes in the Advisory Boards of the ECA Foundation and the EQPA.
The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
Following the notified draft regulation published in 2016 the European Commission (EC) recently published a revised draft regulation on BPA. Read more about Bisphenol A in varnishes and coatings and plastics intended to come into contact with food.
For several years, combination products have been regulated by 21 CFR 4 in the USA. In September 2017, the FDA issued a Warning Letter to a manufacturer of combination products. What did the FDA criticise?
In the first half of Fiscal Year 2017 review you could read about the Warning Letters issued to manufacturers of medical devices during 1 October 2016 through 31 March, 2017. Now, the numbers of Medical Device Warning Letters for the entire fiscal year 2017 (1 October 2016 - 30 September 2017) are available.
The WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. What is the purpose of the document entitled "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices"?