GMP News - Analytical Quality Control

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.

The U.S. Food and Drug Administration (FDA) published a Form 483 after an inspection at an Indian drug manufacturing side. The lack of control over compression machines settings led to not meeting the dissolution specifications. As the investigations were limited to the directly affected batch only, it is not excluded that other products may be affected by the same problem. Furthermore, the stability program was not followed to complete the testing within the predefined time frame.

During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted several new and revised texts and monographs for publication in Ph. Eur. Supplement 11.1, including several general chapters on chromatographic methods.