Regulatory framework for the manufacture of medicines
Good quality is a prerequisite for safe and effective medicines, and we work with a long-term view to ensure our products are of good quality.
- We comply with international standards for medicine manufacture on an industrial scale.
- As we manufacture medicines for various markets within and outside Europe, our production units are regularly inspected by the Swedish Medical Products Agency and the USA’s Food and Drugs Administration.
- Our customers also carry out regular inspections, which provides us with continuous feedback on our quality work.
- The manufacture of materials for trials 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, which certify the operation.
We work with constant improvements and follow up our quality work through annual quality audits in order to safeguard even and good quality in all units.
APL’s quality manager leads and coordinates the quality work together with the production units’ quality managers to create a common and well-established quality system. The local quality managers lead the quality work locally and, in their roles as QP, are responsible for the release of medicines.
Read more in Certificates External link.