"Hi,
my name is Eric Couwenberg, I’m 41 years old, single and I work for Eurovet as a Validation Assistant. My hobbies are photography, football, skiing, diving and travel, but my number one hobby is enjoying all the pleasant things that life has to offer!
Simply put, a Validation Assistant delivers documented evidence that an appliance, system, process or procedure will reproducibly deliver a predefined result. That is to say, a constantly uniform result and quality, and a good and safe product!
This work has everything to do with GMP or Good Manufacturing Practice. GMP is a set of guidelines that we as a veterinary pharmaceutical company must abide by and on which we are inspected and assessed by the Dutch Institute of Health Policy and Management. A company must have this GMP certification to remain in operation.
I will use the acquisition of a new piece of equipment or system as an example of how this works.
The process for equipment and systems acquisition starts with creating what is called a URS or User Requirement Specification – a document that states the requirements and desires that the equipment or system needs to meet. These specifications could be anything from the desired speed, requirements with regard to the finish, to the materials used and of course the required package of documents and drawings.
The next step is to perform IQOQ or Installation Qualification & Operational Qualification protocol tests and controls to test that the machine is correctly installed, that it is functioning well and meets the stated requirements. We also check the delivery of the desired documentation and verify that the required internal procedures are in place.
As soon as the IQOQ has been successfully completed, the equipment can be released and put to its intended use. Next we perform a PQ or Process Qualification to demonstrate that the equipment delivers the desired result within the process it operates. A PQ is always conducted in triplicate to rule out any coincidences and to prove reproducibility.
The final step is to process the results into a report that contains all the conclusions. If the results meet the requirements, the machine or system is approved by its owner or by the relevant department head. After that, Quality Assurance can formally release the machine or system by approving the reports.
The machine, system or process has now been validated.
The great thing about working for Eurovet is that the people are fun and enthusiastic and the work is never monotonous, routine or boring. We constantly need to anticipate and improve because of ever more stringent requirements and expanded legislation. I see increasing numbers of new projects for the future because the results these past few years have been so good, and that too represents a constant challenge. Bye for now, Eric"