The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021. Although Brexit was a long time coming, there are supply problems for some medicinal products. The Covid-19 pandemic has therefore also prompted the EU to act. Cyprus, Ireland, Malta and Northern Ireland in particular have not yet fully adapted their supply chains.
Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK. Now, the European Commission has decided on a transition period for decommission with regard to exports to the UK.
In a previous News you could read about audit alternatives of Notified Bodies in Covid-19 times. The guideline was based on a document of the Medical Device Coordination Group (MDCG). This guideline has now been supplemented by a question and answer document.
The "Q&A" documents for centralised procedures were revised and published on the EMA website in January. In general, pre- and post-approval advices regarding centralised procedures are given and specially information for applicants of generic or hybrid medicinal products is mentioned.
With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from the production sites to the storage and distribution centres and then on to the local vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also any other temperature-sensitive product in general. The EU GDP-Guidelines contain some specific requirements for temperature-sensitive products in this regard.
Qualification and re-qualification of suppliers and customers are a fundamental part of Good Distribution Practice (GDP). Using online resources and publicly available databases is established as a standard requirement during this process. But relying (only) on information that is easily available to everyone may involve a high risk. In this context, a new post, entitled “Qualifications of suppliers and customers online: reliable or fake news?” has been published in the MHRA Inspectorate blog.
A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.
The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
The issue of data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 10: What regulations must be in place to ensure that in case of business discontinuation (insolvency) of a cloud service provider, the data is completely returned to the client?
Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.
A look at the warning letters to pharmaceutical companies of the last nine months of the current fiscal year (Oct. 2019 - June 2020) shows the most frequent GMP violations found by FDA inspectors. Read more about the Warning Letter Analysis in this article of the GMP Journal