Are you looking to analyze cleaning residues on your finished products?
The analysis of cleaning residues is an integral part of good pharmaceutical manufacturing practices (GMP). Indeed, these analyses are carried out within a regulatory framework related to quality assurance for pharmaceutical products and manufacturing processes.
The risk assessment related to cleaning residue analyses aims to prevent cross-contamination or the appearance of residues during the manufacturing process, which could compromise the quality of pharmaceutical products.
These analyses are mainly carried out when there is a process change.
Our solutions: supporting pharmaceutical manufacturers in the analysis of cleaning residues at the end of their process
FILAB offers pharmaceutical manufacturers high-level expertise and know-how within a state-of-the-art analytical platform to provide services that meet their compliance requirements.
The FILAB laboratory supports you in cleaning residue analysis through the following services:
Our services
Search for cleaning residues in the finished product
Method development and validation of the cleaning process
Search for impurities: residual solvents, inorganic impurities, catalyst residues, related substances...
Training in validation of the cleaning process
Creation of a defect library
FILAB is notably COFRAC-accredited to ISO 17025 for impurity analysis on pharmaceutical products (ICH Q3D context).
