Risk-based qualification and validation of facilities and processes
GMP-compliant approach based on the Annex 15 of EU GMP Guideline and the ECA Guide on Integrated Qualification and Validation.
GMP qualification and GMP validation have to be risk-based in order to estimate the effects of deviations on process stability and product quality on the one hand and to control time and costs on the other.
Nevertheless, qualification and validation require time and personnel resources that are not always available in addition to routine operations. External support from experienced qualification and validation experts is the solution!
Depending on your needs, Valicare experts offer GMP-compliant processing of individual subtasks, comprehensive support or the complete implementation and documentation of qualification and validation projects.
The scope of our services includes GMP-compliant qualification of your equipment and facilities as well as GMP-compliant validation of systems and processes.
The goal of the Valicare experts is to ensure the reproducibility of your manufacturing processes (process validation), cleaning procedures (cleaning validation), analytical methods (method validation) and computerized systems (computer system validation).
Qualification and validation protocols with defined test methods and acceptance criteria are prepared in consultation with the customer and form the basis of qualification and validation activities. The reports contain the results of the tests carried out and the verification of the previously defined acceptance criteria. They are prepared according to customer specifications for each qualification or validation part separately or as an overall document.
The follow-up of changes or deviations and their GMP-compliant documentation with the accompanying processing within the scope of the change control procedure and deviation management are completing our qualification and validation process.
In addition to the routine application of the globally applicable GMP guidelines, including Annex 15 of the EU GMP Guideline, the ECA Foundation's good practice guide on Integrated Qualification and Validation is applied based on customer requests.
Valicare experts were involved in the preparation of the ECA guide. They know how the qualification and validation process can be performed timesaving, cost-effective and without loss of quality through efficient cooperation between manufacturer and supplier.
You will find further information on the individual services on the following pages or just contact us, we are pleased to answer and advise you.