Are you looking to analyze cleaning residues on your finished products?
The analysis of cleaning residues is an integral part of Good Manufacturing Practices (GMP). Indeed, these cleaning residue analysis are performed within a regulatory framework related to the quality assurance of pharmaceutical products and manufacturing processes.
The purpose of risk assessment related to cleaning residue analysis is to prevent cross-contamination or the appearance of residues during the manufacturing process, which could affect the quality of pharmaceutical products.
The analysis of cleaning residues takes place mainly during a process change.
Our solutions: support pharmaceutical manufacturers in the analysis of cleaning residues at the end of their process
FILAB offers pharmaceutical manufacturers high-level skills and know-how in a state-of-the-art analytical facility in order to provide them with services that meet their compliance criteria.
The FILAB laboratory can assist you in the analysis of cleaning residues through the following services
Our services
Search for cleaning residues in the finished product
Method development and validation of cleaning processes
Process audit
Research of impurities: redisual solvents, inorganic impurities, catalyst residues, related substances...
Training in cleaning process validation
Creation of defect library
FILAB is notably accredited 17025 by COFRAC for impurity analysis on pharmaceutical products (ICH Q3D context).
For more information on our cleaning residue analysis services, please contact us: contact@filab.fr – tel: 03.80.52.32.05 or ask for a quote here.
