Quality

Regulatory framework for the manufacture of medicines

Good quality is a prerequisite for safe and effective medicines. We work with a long-term view to ensure our products are of the highest quality.

We follow international standards for industrial-scale medicine production.

As we manufacture medicines for various markets within and outside of Europe, our production facilities are regularly inspected by the Swedish Medical Products Agency and the U.S. Food and Drug Administration (FDA).

Our customers also conduct regular inspections, giving us continuous feedback on the quality of our work. Manufacturing clinical trial material follows the same regulatory framework.

Our manufacture of extemporaneous medicines for individual patients complies with the Swedish medicine standards, SLS and the Medical Product Agency’s enactment LVFS 2010:4.

We also manufacture medical devices. All our activities are inspected by accredited bodies certifying our operations.

Quality system

We continuously improve our operations and undergo annual quality audits following regulatory requirements to safeguard consistently high quality in all our facilities. We are also regularly audited by our customers and follow their procedures and guidelines.

APL’s corporate quality management leads and coordinates quality control together with production facility quality managers to create a common and well-established quality safeguarding system. Local quality managers lead quality control in their facilities and are responsible for releasing medicines in their roles as Qualified Persons (QP).

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Read more in Certificates External link.