Cleaning validation and regular monitoring of cleaning efficiency ensure the quality of medicinal products.
The risk of a spot contamination must be taken into consideration.
In 2015, the requirements for cleaning validation were fundamentally revised with the introduction of the PDE concept. 2023 a new Aide-Mémoire on the inspection of cleaning validation and verification with further details was published by German ZLG, which summarizes the requirements in an inspection on 50 pages.
Does your cleaning validation meet these regulatory requirements? Did you consider spot contamination?
Do you carry out risk-based ongoing monitoring of the cleaning processes?
Before vials can be filled with liquid medicines and sealed, they must be thoroughly cleaned.
What is spot contamination?
In the case of spot contamination, chemical, microbial or particulate contamination is locally limited and is therefore distributed not homogeneously to the whole batch. This can lead to loss of the whole batch or even to a safety risk for patients.
To ensure a safe product and prevent batch loss, Valicare generally performs a risk-based assessment of all contamination types and critical zones prior to cleaning validation.
In addition to the transition points and filling areas, filling technology for liquid products (such as filling needles) or the tablet press/ capsule filler for solid dosage forms is considered a possible hot spot.
What is continuous risk-based monitoring?
For the cleaning procedures, the authorities no longer consider that a onetime validation is sufficient. Rather, you must demonstrate at appropriate intervals that you will still find the required cleaning effect based on the risks.
While cleaning validation or as a separate gap analysis, Valicare creates a risk-based monitoring strategy. This determines the extent and at which sampling points a control of the cleaning success is to be repeated at what intervals.
Conclusion
Cleaning validations are a basis for the safe production of pharmaceuticals. The preparation of the necessary risk analysis offers a variety of pitfalls that must be avoided. Valicare provides you with an understanding of the requirements and shows practical solutions for implementing them in accordance with the directive.
You are welcome to join our webinar on cleaning validation for refreshing your knowledge and get special info about spot contaminations.
Author: Dr. Carsten Börger, Senior GMP Consultant, Teamleader Qualification & Validation
