By knowing the critical process parameters, any deviation occurring in standardized production processes are detected and can be rectified, if necessary. Appropriate tests are carried out to establish acceptable range limits of the determined CPPs.
And this is how rantronik supported our customer, a pharmaceutical global player for animal health, in validating a new sterile production process.
After several years of research and development as well as stability and regulatory submissions of the new product, a new, specially designed manufacturing and filling line was set up after the construction of the new building.
In addition to the current qualification measures, in a very tight schedule rantronik supported the process validation of the new product consisting of a liquid as well as a powder component.
In parallel to the accompanying process optimization of the new processes to be implemented, critical process parameters were evaluated, risk analyses were prepared and all process validation activities were accompanied, recorded and evaluated.
Do you also need support in defining CPPs for your processes or in general process optimization?
Contact us at any time - we will be happy to support you and provide you with comprehensive advice on your processes.