GMPveiledningene

GMPveiledningene refers to the collection of Good Manufacturing Practice guidelines used in Norway to regulate the manufacture of medicinal products and related materials. They provide the framework for ensuring product quality, safety, and efficacy throughout the supply chain, from input materials to finished products and distribution.

The guidelines are issued by national authorities, notably the Norwegian Medicines Agency (Statens legemiddelverk), often in coordination with European bodies. They are designed to align with EU/EEA GMP directives and the EudraLex GMP rules, and they are updated periodically to reflect scientific advances, regulatory changes, and lessons learned from inspections.

GMPveiledningene cover a broad set of topics essential to compliant manufacturing. Core areas include quality management systems, personnel responsibilities, facility and equipment suitability, and data integrity. They also address production controls, quality control testing, validation and qualification of processes and systems, and change control. The guidelines emphasize handling deviations, investigations, and corrective and preventive actions (CAPA), supplier qualification, material handling, packaging and labeling, storage and distribution, and recall procedures. Environmental monitoring and aseptic processing are included where applicable, as are sanitation, maintenance, and calibration of equipment.

In practice, the GMPveiledningene guide day-to-day operations and serve as a basis for regulatory inspections. Compliance supports market authorization, product safety, and public health, while non-compliance can lead to enforcement actions, remedial plans, or license withdrawal.