GMP News - Analytical Quality Control

How are OOE and OOT results in the pharmaceutical industry to be recorded and assessed nowadays? To answer this question, the ECA Quality Control Working Group and representatives from authorities and industry compiled a guidance document about the handling of Out-of-Expectation (OOE) and Out-of-Trend (OOT) results. Find out more about the 70 page OOS/OOT guidance document.

The India-based pharmaceutical manufacturer Mylan Laboratories received a Warning Letter by the FDA in April 2017. The FDA inspector found that over 70% of initial OOS results were invalidated without sufficient investigation to determine the root cause of those OOS results and that there was no appropriate trending. Get more information about the Mylan Laboratories FDA Warning Letter.

Incorrect sampling has led to an FDA Warning Letter for an API manufacturer in China. The FDA inspectors criticised that around 10% of the API batches manufactured exceeded the impurity limit set. Read more about this FDA Warning Letter.

In January 2017, Sato Yakuhin Kogyo Co. Ltd., a pharmaceutical company in Japan, received a Warning Letter from the FDA. During the FDA inspection, incomplete data were criticized in the HPLC and UV analysis. Find out more about the FDA Warning Letter issued to Sato Yakuhin Kogyo.

In January 2017, FDA's Office of Pharmaceutical Quality revised the document "MAPP 5310.7" on the acceptability of standards from alternative compendia. This important FDA document is often unknown among the pharmaceutical industry. Learn more about the most important aspects of FDA's document "Acceptability of Standards from Alternative Compendia (BP/EP/JP)".

In the Pharmacopeial Forum of the USP the revision of the General Chapter <197> on Spectrophotometric Identification Tests is proposed. As part of the revision, the sections NIR and RAMAN would be newly included. Get more information about the planned update of the USP on identification tests.

The United States Pharmacopeial Convention (USP) approved a revised version of general chapter <1225> Validation of compendial Methods. Read more about the Validation of Analytical Procedures.