The recording of the session, a Q&A paper, and the guidance document are available in the members’ area. If you are not yet a member, you can register here for free.
The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. Version 1 of the new document is now available for download free of charge in the AQCG members' area.
After the final texts of the ICH Guidelines Q2(R2) and Q14 were adopted at the ICH Assembly Meeting on 31 October and 01 November 2023, the documents are now available for download on the ICH website.
The ECA Analytical Quality Control Group (AQCG) met in-person on 20 November 2023 in Düsseldorf/Neuss, Germany. During this Board Meeting, several decisions were made concerning both the composition of the Board and the work program for the coming months.
Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2023. As in previous years, we have again performed an evaluation with regard to deficiencies in the stability programme.
The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. Based on a review of record, the authority found several CGMP violations. These concern inadequate identity testing of incoming components and finished drug products. Furthermore, an adequate stability testing program was not implemented.
The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.
In January 2023, a new 4th edition of the IUPAC Compendium of Terminology in Analytical Chemistry (Orange Book), was published by the Royal Society of Chemistry, UK, updating the previous 1997 edition after a gap of 26 years.
Since the beginning of November, the updated version of chapter "<621> Chromatography" has been available on the USP Pharmacopeial Forum website and published for comment. Comments on this draft, which is based on the previous version from October 2023, can be submitted until 31 January 2024.
In the context of technical and scientific developments in the field of certain products containing monoclonal antibodies, the EMA is revising its guidance document "Development, production, characterisation and specifications for monoclonal antibodies and related products" and other related documents.
