GMP News - Validation

In June you could already read about a WHO draft guideline on the topic of limit values in cleaning validation. This draft has now been significantly revised and re-issued with a new title "Point to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation". What changes have been made?

In the last newsletter you could already read about a new Aide-Memoire of the PIC/S for the inspection of health-based exposure limits (HBEL). At the same time, the PIC/S has published a Q&A document on HBEL and cross-contamination. What is behind this Q&A paper?

Data integrity issues remain at the focus of FDA inspections. Insufficient or missing controls to ensure the integrity of electronic test data were one of the reasons for the Warning Letter issued to the American company Stason Pharmaceuticals.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.

The issue of (cross-) contamination and, in this context, cleaning validation have played an important role in the GMP environment for decades. For some years now, health-based exposure limits have been added as a possible alternative. In a draft guideline, the WHO has addressed this topic.

End of May, another new part under the heading "GMP Flexibilites" was added to the Questions & Answers document prepared by the EC, the CMDh, the Inspectors Working Group and the EMA. This new part now includes special features for the qualification of equipment (question 6.2).

In order to be able to continue to provide the population with high-quality, effective and safe medicinal products during the Covid-19 pandemic, Europe is taking exceptional measures. A Q&A document has been prepared in cooperation between the European Commission, the Coordination Group on Mutually Recognised and Decentralised Procedures (CMDh), the Inspectors Working Group and the European Medicines Agency (EMA). At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites".