Cleaning validations in the production of active ingredients and pharmaceuticals have been required since the 1990s. Particularly for multi-product plants and equipments, the aim is to ensure that contamination of the actual product with the pre-product is prevented. The same applies to the prevention of contamination with cleaning agents and microbiological or particulate contamination.
Since this is not a new concept, one could think that all aspects are sufficiently known and taken into account? But, unfortunately not.
On one hand side, this is due to the fact that in the period from 1990 to the present day, the requirements for cleaning validation have been updated and substantiated by the authorities and in some cases for existing cleaning validations the current state of science and technology has not been taken into account.
On the other hand, it is due to the fact that with new classes of medicinal products, production processes have been introduced for which the previous concepts of cleaning validation does not fit, such as advanced therapy medicinal products (ATMPs).
This topic is the subject of a new technical article by Raimund Brett, Principal Consultant at gempex, published in pharmind 12-2021:
Cleaning Validation - Regulations and Guidelines / Toxicology Acceptance Criteria / Examples from the Practice.
The German language article is available at GMP-Knowledge.
For questions on this topic, please contact Raimund Brett via contact@gempex.com.