GMP NEWS 2020

The European Medicines Agency, EMA, as well as the EDQM have extended their deadlines for submitting risk evaluations for Nitrosamine Impurities in medicinal products by the Marketing Authorisation Holders.

A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.

In response to the COVID-19 outbreak, FDA has decided to postpone most foreign inspections until the end of April.

 In a Warning Letter to an Indian manufacturer, the FDA notes that the firm lacked adequate testing for incoming API and relied on the suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.

A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.

Some major European industry associations call for a UK-EU Mutual Recognition Agreement to avoid drug shortages and other problems.

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?

The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations".

In an interesting Warning Letter, the FDA replies to a letter from a pharmaceutical manufacturer that had received a 483 deficiency report in which the FDA criticized, among other things, deficiencies in process validation. Read more about the correspondence.