System of rules for the manufacture of pharmaceuticals

APL complies with international standards in the manufacture of pharmaceuticals on an industrial scale. Pharmaceuticals are manufactured for different markets within and outside Europe, which means that the factories are regularly inspected by the Medical Products Agency and by the FDA (the Food and Drug Administration).

Our clients also carry out regular inspections which gives us continuous feedback to the quality system. Manufacture of trial materials follows the same system of rules. Manufacture of extemporaneous pharmaceuticals, manufacture for individual patients, complies with Swedish pharmaceutical standards, SLS.

SLS is an adaptation of GMP for industrial manufacture and APL has a well developed system for the manufacture of individually adapted pharmaceuticals for patients with special needs. APL also manufactures medico-technical products. These activities are inspected by accredited bodies which certify our operations.

Quality system

At APL we work for continual improvement and follow up quality efforts in annual audits to guarantee a uniform good quality in all departments.

The APL Quality Assurance Director leads and coordinates this work together with the heads responsible for quality in the production units, in order to create a common and well established quality system.

Local heads responsible for quality lead the work at the local level and are in their role as QP (Qualified Person) responsible for the release of pharmaceuticals.