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This year we have received, for he 6th time, the GMP (Good Manufacturing Practice) qualification that is mostly used in the pharmaceutical and food industries. In the European Union supervision is carried out by national regulation agencies. GMP is the general collection of methods employed for securing product safety and continuous high quality. Its two main components are the effective manufacturing procedures and supervision which complement and act on each other.
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In the quality assurance system the quality assurance, the GMP guidelines and the principles of quality supervision are interwoven. According to the GMP regulations the reliable solution of quality related matters need such standardized and flawlessly functioning quality assurance system and supervision that also incorporates the GMP guidelines.
The main principle of GMP is taking into consideration and realizing the following measures in order to achieve quality, to the satisfaction of those concerned
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required measuring and supervision, that is quality control
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exacting and strict regulation of processes
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procedures carried out in line with the specification
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all factors impacting quality: staff, facilities, equipment.
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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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