IDEXX is the global market leader in the fields of veterinary diagnostics, veterinary practice management software and water microbiology tests. The company originated in the USA, employs over 9,000 people worldwide and offers its products in more than 175 countries around the globe. It aims to promote the health and well-being of pets, people and farm animals.
Like many companies operating in the world market, IDEXX has to meet a variety of requirements imposed by the different regional regulatory authorities. Some companies require full GMP, others utilise the prestige they gain with a product manufactured in compliance with GMP.
But what to do when the respective authority does not regulate the product in question? IDEXX Switzerland GmbH had itself audited for its veterinary diagnostics by the independent company Bureau Veritas and thus obtained GMP certification.
The plant qualification was to be carried out in parallel together with gempex-experts from Switzerland as a measure arising from the certification audit.
The risks were ascertained in a team with consultancy and moderation by gempex. Qualification steps and procedures were established in a qualification master plan and tasks were completed cooperatively. Training on GMP fundamentals and the basics of risk analysis and qualification procedures was provided prior to the respective qualification phases.
IDEXX obtained confirmation of the certification without any problems in the course of the surveillance audit that followed.
More information about this project is provided under references.