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.
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.
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
During 2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.
In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.
There are only a few days left until the UK will leave the EU. On 01. January 2021 the UK will be considered a "Third Country" with massive consequences for the GMP environment for medicinal products and APIs. Now the EMA published a new Question and Answer Document which clarifies a number of questions which have been raised during the Brexit negotiations. Please read more about EMAs Q&A Document