- Research is expensive, and moreover – certainly with microbiological research – the results are not known until late. Often it will no longer be possible to trace the products;
- In order to obtain statistically reliable results, it is necessary to examine a large number of samples. This costs a lot of time and money;
- The feedback of research results to the production process is often insufficient (possible), because many production data can no longer be retrieved once the research results are known.
Good Manufacturing Practice is also abbreviated to GMP and is the result of the aforementioned causes. It is a production method based on the assumption that good process control is essential for good quality of the end products. By controlling the process, quality can be better guaranteed. To achieve this, GMP often sets concrete requirements for, among other things, building regulations and requirements for business premises and equipment, regulations for water supply, waste processing, personal hygiene and hygiene in the production or preparation of foodstuffs and a cleaning plan. GMP is mainly used in the food, pharmaceutical and health care industry.
Some principles of GMP are:
- All raw materials and packaging materials are recorded and must meet the specification requirements;
- The quality of raw materials and finished products are tested;
- All procedures are laid down in so-called SOPs (Standard Operating Procedures), also known as work instructions;
- All personnel are qualified and trained for the work to be performed. Tasks and responsibilities must be defined;
- Factory and production conditions are designed and monitored to avoid contamination and mix-ups;
- Changes in work regulations and possible deviations in the procedures are recorded;
- It is established who is responsible for the quality of the products.
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