Qualification & Validation

The GMP-compliant manufacture of medicinal products and active ingredients, cosmetics and foodstuffs is a prerequisite for successful market authorization and the marketing of products.

Quality assurance plays a central role, as quality deviations have a direct impact on consumer health. In order to comply with the strict guidelines of the authorities, e.g. the European Union or the US Food and Drug Administration (FDA), the validation of manufacturing processes and the qualification of equipment, buildings and premises is a prerequisite.


With an experienced team, Chemgineering develops customized measures to achieve a status that meets the necessary regulatory requirements.We create all relevant qualification, validation and compliance documents as well as standard operating procedures in the form of SOP templates. For audit-proof systems and processes that withstand audits at the first attempt.