The cleaning of production equipment constitutes a critical phase in ensuring the quality of a medicinal product. Whether the routine procedures of cleaning are safe, effective and repetitive is confirmed through cleaning validation.
One of its elements is validation of the analytical method that is used to monitor the residues on the surface of the production equipment.
Within the framework of validation of the cleaning process we offer:
– establishing a method for collecting samples from the equipment`s surface,
– checking out the stability of collected samples,
– establishing an analytical method to determine the residues of the analyzed substance (together with determining the recovery of the analyzed substance from the swab),
– validation of the analytical method for determining the residues of the substance in samples after cleaning,
– final report.
Validation is carried out in accordance with the guideline included in the ICH Q2(R1).