GMP NEWS 2020

Since the beginning of the pandemic and the associated travel restrictions, the FDA has been hesitant to decide whether to conduct distant assessments. Now, more and more criticism is spreading.

The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic.

The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.

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

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.

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.

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.

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.