GMP NEWS 2022

According to the EU GDP Guidelines, wholesale distributors must obtain their supplies of medicinal products only from persons who themselves hold a wholesale distribution authorisation or a manufacturing authorisation which covers the product in question. Thus, all suppliers must be qualified in an adequate way. But what is the rationale for this point and how to implement the requirements?

The second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" was finalised in April 2022 and is available on the ICH website under the heading "Quality Guidelines". As a result of this revision, the chapter "<232> Elemental Impurities-Limits" of the USP has now been revised and published for comments on the USP Pharmacopeial Forum website.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Glenmark Pharmaceuticals Limited. During an inspection at the site in Goa, India, several GMP violations were found. The company failed to thoroughly investigate OOS results. In addition, the FDA considers the chromatographic data integration procedure as inadequate.

The EMA started a pilot to assess whether using raw data can help speed up and improve the medicine-evaluation process. Read more about EMA´s Proof-of-Concept Pilot.

The FDA published a revised draft guidance on frequently asked questions about the agency´s regulation of expanded access to investigational medicinal products. But, what exactly is expanded access?

There has been a recent accumulation of Warning Letters from the U.S. Food and Drug Administration (FDA) to manufactures of hand sanitizer products. At the end of November, a further letter was published. In this case, FDA laboratory analyses showed that the ethanol content of several batches was too low. In addition, the FDA has also found numerous GMP violations. There was already a lack of the necessary basic SOPs.

The ECA regularly provides evaluations of the FDA Warning Letters per fiscal year. In 6th place in the fiscal year 2022 (Oct. 2021 - Sept. 2022) are deficiencies regarding the topic of cleaning/cleaning validation. What was found?

The U.S. FDA warns five companies for illegally selling food and beverage products containing cannabidiol (CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use.

The European Medicines Agency has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and will help to identify suitable RWD sources.