Analytical Quality Control News

FDA Warning Letter: Missing Ongoing Stability Studies for APIs

In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.

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USP plans new Chapter on Process Analytical Technology (PAT)

The United States Pharmacopeia (USP) is developing a new General Chapter dedicated to Process Analytical Technology (PAT), aiming to provide guidance on its definition, attributes, enablers, and practical applications in the pharmaceutical industry. Comments on the proposed outline are due to the USP by 28 April 2024.

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The new AQCG ECA AIQSV Guide: Download, Training, Comments

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. It is intended to be a practical guide for risk-based instrument qualification and system validation.

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EMA/CMDh: Appendix 1 for Nitrosamines Updated Again

The nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.

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EDQM: Top Ten Deficiencies for CEPs

In February 2024, the EDQM has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections.

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Swissmedic: Nitrosamine Requirements updated

Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.

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FDA Warning Letter: Observed particulates in repackaged drug components

In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.

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EDQM: Addendum 11.5 to the European Pharmacopoeia available

The Supplement 11.5 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 01 July 2024. All CEP holders are required to harmonise their specifications and thus the respective CEPs with the new monographs.

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EMA/CMDh: Nitrosamine Q&A Document revised

The EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" was updated again in January 2024 and is now available in revision 20. Like the three appendices, the Q&A document is published on the EMA website and can be viewed under "Questions and answers".

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EDQM: Overview of Reference Substances updated

The list of available reference standards is revised and published at regular intervals on the website of the EDQM. This comprises more than 3100 substances, including not only chemical reference substances but also herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials in accordance with Ph. Eur. methods.

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