2021 virtual GMP audit successfully completed

In a three-day audit, Minitube´s semen extender production site has recently been reconfirmed of complying with GMP standards. As the first European company, Minitube was granted a virtual audit, due to pandemic restrictions.

Since its founding 50 years ago, the primary focus of Minitube has been on delivering high quality products and services to its customers. The effective quality management system for all divisions of our company has been confirmed through several certifications that are audited periodically. We are especially proud of our extender production being GMP-certified for 10 years now.

The APVMA (Australian Pesticides and Veterinary Medicines Authority) as an accredited agency has recently completed its review of the Minitube manufacturing site for semen extenders. The auditor recognized the GMP compliance of the facility in Tiefenbach, Germany, and all related organizational and administrative structures for the fifth consecutive time since 2012.

This time, everything was different: due to the Covid-19 pandemic, Minitube was the second company worldwide to be granted a virtual audit by the APVMA.

Within a three-day audit in April 2021, all steps in the manufacturing process were extensively examined. An essential part of the audit is the assessment of the production and operating facilities. For the virtual audit, the inspection was carried out with VR glasses. Although he could not be present in person, the auditor was able to experience the inspection live, get an overview and assess our working methods with regard to compliance with the GMP guidelines.

The auditor praised the excellent preparation and implementation of this virtual audit and the input of all employees from the departments involved – resulting in an excellent rating. In addition to the positive overall impression, the flawless condition of Minitube’s production facilities and the complete and impeccable quality management documentation of our production were decisive for the positive evaluation.

With fully automated production lines, GMP approved facilities and processes with comprehensive and consistent quality control, Minitube sets the benchmark for highest quality standard for semen extenders in the industry.