19.12.18

GMP compliance of Minitube´s extender production facility confirmed

The APVMA (Australian Pesticides and Veterinary Medicines Authority) as 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 organisational and administrative structures for the fourth consecutive time since 2012.

In addition to the positive overall impression of facilities, offices, workshops and warehouse, the flawless condition of our production facilities and the complete and impeccable quality management documentation of our production were decisive for the positive assessment.

GMP stands for “Good Manufacturing Practice” and ensures veterinary chemical products are consistently manufactured to the appropriate quality standards for their intended use - and in accordance with the particulars and specifications of their registration. The production methods must meet strict regulations and guidelines of considerably higher standards as compared to DIN ISO norms. Manufacturing procedures must be exactly described and documented at every level of operation. Seamless traceability of all materials and operating processes must be assured. Quality control as an integral part of GMP production must be effective, consistent and fully documented.

Within a two-day audit in October 2018, all steps in the manufacturing process were extensively appraised, such as quality assurance of raw materials, formulations including packaging or labelling, the microbiological reduction treatment, analysis and testing, storage, product release following production and subsequent release for shipment. The GMP guidelines are validated for all extenders for animal semen, whether powder or liquid, being produced in the high-tech clean room of the Minitube headquarters in Tiefenbach.

Minitube’s extender production facility was designed with the know-how of GMP experts and provides maximum automation of the production procedures. Raw material flow during manufacturing is handled in a completely closed system for maximum safety and quality. The production software has been especially developed for Minitube to ensure complete control and documentation for weighing and mixing the extender components.

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

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Quality signed and sealed: successful ISO 9001:2015 re-certification