Filling product into open containers with leaks above the packaging lines? Not a good idea - A current FDA Warning Letter provides information.
The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic.
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?
The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.
EMA has published a Guidance document, providing points for consideration relating to Distant Assessments.
What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.
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
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.
Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.
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.