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Quality management
KoVax continually strives to meet - and exceed - the
regulatory and quality standards of the markets where our
products are sold. Before our products are released, they are extensively tested
by external labs and in our own QC laboratory.
QC Lab
Vaccine safety and potency is verified on every batch by
testing in target species.
This is performed in external laboratories on contract.
From process- and temperature-control systems to clean
room operations, we maintain and document a consistent
quality standard during manufacturing.
In accordance with the regulation requirements for current Good
Manufacturing Practice (cGMP), every batch of vaccine is produced in compliance with these regulations and documented in written protocols/reports (batch records).
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KoVax Statement of Compliance |
- KoVax operates a Quality Management System based on policies and procedures which are documented.
- The scope of KoVax's work includes manufacturing, quality assurance systems and support functions, such as materials purchasing and logistics. Our Quality Management System scope covers all of these functions.
- We manage our processes and activities within our Quality Management System with a focus on ensuring the total satisfaction of our customers. We do this by articulating the sequence and interaction of the processes, identifying success criteria and required methods, ensuring available resources, and monitoring/ reviewing the health and effectiveness of the process for the purpose of driving continual improvement.
KoVax's customers are KOI and Carp breeders and marketing companies
- KoVax Management and personnel bear the responsibility for Quality output. Quality output is second only to Safety in the production facility priorities.
The KoVax Quality System is an integral part of the business planning model and is based on the following items:
- Management Review and internal audits provide for continued review and update to the entire Quality System.
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