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
A Task Force with members from the pharmaceutical industry, plant manufacturers and engineering companies has created the ECA Guide. The Guide was designed based on the requirements of EU GMP Annex 15 and supplemented by aspects of ASTM Guide 2500. The Annexes are very important for the applicability of the Good Practice Guide. They contain sample documents and templates that are successfully used in the pharmaceutical industry and in plant engineering and construction. Read more about the Guide in the GMP Journal Article.
Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.