Cleaning validation is the methodology used to demonstrate in a reproducible manner that after adequate cleaning, a plant or equipment does not contain substances or materials that could compromise the quality of the subsequent product manufactured in the same plant. This is crucial for patient safety, as residues can pose severe health risks. Thus, cleaning validation is one of the essential regulatory requirement in the good manufacturing practices (GMP) and it is a requirement in different sectors, especially within pharmaceutical and food industry. The cleaning validation is a critical element especially in the GMP of shared facilities. Successful cleaning validation begins with identifying potential residues and establishing acceptable carry-over limits, based on a thorough toxicological assessment using PDE (Permitted Daily Exposure) values or ADI (Acceptable Daily Intake) of the critical substance. We do offer:
