The GMP-compliant manufacture of pharmaceuticals and active ingredients, cosmetics and food is a prerequisite for a successful marketing authorization and the marketing of the products. Quality assurance plays a key role since quality deviations can have a direct impact on the health of consumers. In order to comply with the strict guidelines of the authorities, e.g. the European Union or the US Food and Drug Administration (FDA), validation of the manufacturing processes and the qualification of equipment, buildings and premises are absolutely necessary.
With an experienced team, Chemgineering develops individualized measures to achieve a status that meets the required regulatory requirements. We prepare all the relevant qualification, validation and compliance documents as well as standard work instructions in the form of SOP templates. For audit-proof systems and processes that withstand audits from the very onset.
Our services in the field of qualification and validation:
