GMP News

A recently published 483 for a sterile manufacturer shows once again that the issue of supplier control is an ongoing concern for the US FDA. However, this is not the only focus in this report, as there are 13 other, sometimes detailed (and hair-raising) observations over 20 pages.

More than two years ago, the FDA published a Guidance for Industry on remote evaluations: "Remote Interactive Evaluations". Now the successor has been published as a draft. Not much has changed, except for one important innovation.

The World Health Organization (WHO) has published a draft working document entitled Bioanalytical Method Validation and Study Sample Analysis (QAS/23.925). Comments should be submitted by 21 January 2024.

The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research (CDER) has provided a webinar on the Drug Supply Chain Security Act (DSCSA) implementation.

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.

The Austrian Medicines and Medical Devices Agency has entered a new GDP Non-Compliance Report into the EudraGMDP database. The authority writes that major deficiencies were detected in the quality systems of a wholesale distributor, also related to the lacking awareness of the Responsible Person. As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.

FDA Warning Letters are extremely important for pharmaceutical companies. This is once again demonstrated by the case of a Swiss company that received a Warning Letter on September 11, 2023. Read more in this GMP News.

What "findings" did the FDA find for medical devices in fiscal year 2023? Read the analysis here.

In the US the Center for Devices and Radiological Health is responsible for medical devices. The CDRH is also increasingly involved in harmonisation efforts. What is planned?

Following the successful completion of the Biological Standardisation Programme study to establish Hepatitis C Virus (HCV) Biological Reference Preparation (BRP) batch 2 for nucleic acid amplification techniques (NAT), the result has been published in the online journal Pharmeuropa Bio & Scientific Notes: "Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT assays BRP batch 2".

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.

Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.