Verification, Qualification & Validation
Our consultants have extensive experience with the evaluation, verification, qualification and validation of processes, installations, equipment, procedures and methods of analysis. We assess whether you are GMP compliant and we help you take the required actions to comply with this norm.
IQ, OQ and PQ Protocols
In order to be GMP compliant your processes, installations, machines, procedures and methods of analysis require and need to adhere to IQ, OQ and PQ protocols. These protocols help verify whether you live up to the specifications stipulated in the FDA, GMP and GLP guidelines.
Installation Qualification (IQ)
Our experts assess whether your equipment is installed properly. Points of attention include utility provisions, component specifications, construction materials, user manuals and safety measures.
Operation Qualification (OQ)
Our experts assess your operational efficiency. We assess i.a. whether your machines can perform within the set specifications and limits. OQ evaluation is based on calibration results, control functions and general operation results.
Performance Qualification (PQ)
In this initial validation we check all parameters, sensors and programs. Our consultants use the PQ to advise which parameters and programs need annual revalidation.
Interested?
Are you interested in our services or do you have additional questions? Please call us at +32 9 324 70 80 or fill out the form below. We look forward to speaking with you.
