GMP News - Quality Assurance

The latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

As a result of the increased demand for disinfectants, especially for hand hygiene, the number of inferior products with deficiencies in composition and/or approval is increasing rapidly. This is accompanied by an increase in Warning Letters from the FDA to disinfectant manufacturers.

In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.

EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement? 

Recently the FDA issued a Warning Letter due to lack of control over computer systems and violation of data integrity. During the inspection the use of multi user access to raw data files and falsification of records were observed.

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.