GMP News - Analytical Quality Control

The continuous manufacture of medicinal products is a young, spreading type of modern pharmaceutical production. In contrast to classical batch manufacturing, these processes run continuously, i. e. dosing and product withdrawal run uninterrupted and are continuously monitored. A recent USP article discusses what release testing might look like.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an over-the-counter (OTC) drug product manufacturer in Los Angeles. Several GMP violations were identified in the area of laboratory testing, stability program, and quality oversight. In a previous inspection in 2018, similar observations were made. Therefore, the FDA considers the executive management oversight and control over the manufacture of drug products as inadequate.

In June 2022, the U.S. FDA issued a Warning Letter (WL) to the Spanish company "Bioiberica, SAU" after having inspected its site in January and February 2022.

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.

In the Pharmacopeial Forum, PF 48(4), a stimuli article entitled "Consistent Terminology for Advancement of NMR Spectroscopy" was published. According to the authors, the paper builds the foundation for a modular, coherent, and standardized terminology, a condition necessary for a healthy life cycle of research data, including their management and reuse.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.

Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.