There is a quality management system operating in a company (HACCP), being independent from other company’s work places. To the basic goals of quality management department belong the establishing of new testing methods based on quality parameters, forming of specifications, their revisions and up-dating. A system of:
– sample protection and their disposal after testing
– reference sample preservation has been introduced.
The methods of testing, measuring, identification and evaluation are subject to validation where appropriate records are kept. Where required, regular work environmental tests are carried out.
The records can testify that the sample, inital and packing material, intermediate and non-filled products and their testing have already been tested in compliance with the specifications valid. Special attention is given to the inspection of the primary packaging and printed packaging material as well. Each batch is marked with a number or identification code, providing thus sufficiently protected conditions to avoid their interchange. No batch of the finished product is detached and released for the distribution until a final test report and/or certificate of analysis has been signed by authorised person with final result “approved”.
An authorised person will ensure, prior to each druge release, with a written confirmation of the certificate of analysis, that the requirements resulting from the Decision on production permit and Decision on registration and/or Decision on
supplementary programme approval , respecting the principles of Good manufacturing practice in production and quality management, application of the manufacturing methods validated, test methods, machine equipment and devices.
The metrological aspect is guaranteed externally by State Control Institute for Metrology in BanskáBystrica (isnpection of measuring devices) and by a certified department Chirana, Injecta factory in Stara Tura (aeroscopic atmosphere inspection)