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According to the EU-GxP guidelines, systems and processes that are directly involved in the manufacturing process for product groups such as pharmaceuticals, active ingredients, cosmetics, food, animal feed, and medical devices and thus have an influence on product quality must be qualified and validated. The requirements of the Guide to Good Laboratory Practice are addressed at laboratories conducting non-clinical studies on test objects such as pharmaceuticals, pesticides, biocides, cosmetics, veterinary medicinal products, food additives, feed additives, and industrial chemicals. Systems and processes used to inactivate human sample materials (body fluids, tissues, cell cultures, etc.), microorganisms, cell cultures, endoparasites – including their genetically modified forms – also fall under this category.
A requirement of the principles of good laboratory practice is that equipment, including validated computer-aided systems used to collect, record, and reproduce data and to control the environmental conditions relevant to the test, must be of adequate design and performance. If your autoclave is directly involved in studies on the above-mentioned product groups, its suitability in terms of design and performance must be proven. In detail, the supervisory authorities will define the requirements for qualification and validation implementation and documentation in more detail by specifying standards, guidelines, etc. or they may follow standards because the standardisation also moves within certain limits.
Qualification and Validation
As an autoclave operator involved in your manufacturing process – or as a laboratory operator – you are responsible for your manufacturing process or for the results and conclusions of your study. Qualification and validation is often carried out with the help of an appropriately qualified service provider. Since only you can define the product-specific requirements for your process, close cooperation between your specialist departments, the qualifier/validator, and the autoclave manufacturer is necessary.
Exhibitor: Systec GmbH