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The production site, manufacturing the N.I.C.S. products, received in 2022 for the 10th time the GMP (Good Manufacturing Practice) certification. GMP is the internationally accepted, reliable and traceable standards in which the most effective guidelines, manufacturing procedures, control methods are collected in order to ensure the consistent product safety and quality. It is used generally in the pharmaceutical and food industries. National regulatory agencies coordinates inspections in a form of an audit in every single year to verify the compliance of the manufacturing sites.
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Unified organized, properly functioning quality assurance and quality control system including the GMP guidelines is required for a successful audit.
The key for the outstanding and consistent quality of the products made in accordance with the Good Manufacturing Practice:
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not only the measurements and controlling relating the raw materials, the so called quality control;
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but taking continuous control of every single factor (for example equipments, tools, personnel, premises) affecting the general quality,
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the maintenance of the reliable and traceable standards throughout the whole manufacturing processes (from the product development to placing it on the market);
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accurate regulations and continuous compliance with the rules.
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A widespread concept of quality assurance includes everything that can affect product quality alone or combined with other factors.
Good Manufacturing Practice is part of the quality assurance that enables products to be manufactured and supervised according to quality regulations at all times meeting the requirements needed for market release and realizing the goal for which they were developed.
Good documentation is a key element in ensuring good quality. Well-formulated documents eliminate misunderstandings and allow the batches to be traced and they also provide subsequent examination of their history.
Quality regulations (specifications) contain the required standards relating to all materials or products utilised or produced in the manufacturing process, that is the necessary requirements for appliance.
Production technology regulations define which raw materials can be used and describe the production and packaging processes.
The procedure commands or operating instructions and standard operating regulations contain instructions for performing certain procedures.
The records contain the already completed operations, the history of the batches up to release and all the data relevant to the quality of the products.
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