Your need: validate the cleaning processes of your pharmaceutical products
Cleaning plays a crucial role in the production process of a pharmaceutical product. Indeed, the quality and the conformity of a product will depend on the level of insurance against the risks of contamination. These contaminations can be of chemical, microbiological or particulate origin, and occur at several stages of the process.
Consequently, the cleaning operation must be validated in accordance with the regulatory requirements in force. FILAB supports you in this process.
Validation of cleaning processes in pharma: what does the regulation say?
For European countries, the obligations to validate cleaning processes are mainly based on GMP (Annex 15), which specifies that: “cleaning operations must be validated to confirm the effectiveness of the cleaning procedure”.
At the international level, these obligations are governed by the US GMPS (21 CFR 210 – 211). Subsequently, it is the FDA that is in charge of controlling the correct application of the cleaning process validation obligations.
In France, the Official Bulletin N°2007/1 bis on Good Manufacturing Practices (GMP) has come to specify the objective of cleaning pharmaceutical products in a concern for quality control and reduction of contamination risks. Thus, a cleaning method must meet 3 requirements: eliminate the contamination, not alter the support and not be a factor of contamination or a vector of contamination transfer.
FILAB: a service dedicated to residue analysis as part of the validation of your cleaning processes
The FILAB laboratory offers tailor-made support to pharmaceutical manufacturers in the validation of their cleaning processes. Our analytical services, some of which are COFRAC ISO 17025 accredited (www.cofrac.fr), are performed using validated and documented methods, in a GMP context, thus helping you to bring your activities into compliance with the regulations in force.
Thanks to its state-of-the-art analytical equipment and varied internal skills, FILAB performs the following analysis
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Analysis of organic contaminations by TOC meter, GCMS, LCMS
Search for traces in a cleaning product (detergent, oil, lubricant...)
Surface analysis by SEM-FEG or Optical Microscope
Inorganic contamination analysis by ICP-MS and CLI
Particle count according to USP 233
Development and validation of analytical methods according to ICH Q2
Support for the creation of a default library
FILAB is accredited by the COFRAC for impurity analysis of pharmaceutical products (ICH Q3D context).
For more information on our pharmaceutical cleaning process validation services, contact our specialists at contact@filab.fr or by calling 03 80 52 32 05.
