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.
Environmental aspects have always been dealt with sensitively within APL. All our properties, units, products and services impact on the environment in some way, and we have chosen to focus on the most important aspects.
We work towards constant improvements and a sustainable company. This means that we are constantly reviewing our processes to minimise waste of resources. The result is less environmental impact, efficient processes, better finances, a better customer offering and a contribution to society for sustainable development.
The Global Goals and the 2030 Agenda for Sustainable development
APL has joined the 17 UN Global Goals and the Agenda 2030 for Sustainable development.
Based on the owner's expectations of APL as a state-owned company, our mission, our connection to, for example, the UN Global Compact and Fossil Free Sweden, as well as our stakeholders' expectations and ambitions, APL has chosen to prioritize six of the goals:
- Good health and well-being (Goal 3)
- Clean water and sanitation (Goal 6)
- Affordable and clean energy (Goal 7)
- Decent work and economic growth (Goal 8)
- Responsible consuption and production (Goal 12)
- Climate action (Goal 13)
Based on these, we have formulated four long-term goals for long-term sustainable growth and profitability, with the aim of 2030:
- Develop and provide a quality assured and medically purposeful range of individualized extemporaneous drugs (Goal 3)
- Create growth with increased productivity as well as being an attractive employer that continually further develops our employees' skills in an equal environment that promotes diversity (Goal 8)
- Reduce the use of fossil energy sources and logistics services and minimize resource use and emissions in our production (Goals 12, 13)
- Actively ensure that employees and suppliers comply with the APL Ethical Guidelines and Code of Conduct and actively protect human rights with zero tolerance against corruption and bribery (Goals 8)
Work to reduce waste
Our goal is to reduce the overall amount of waste, including medical waste and to increase the proportion of waste being recycled. This contributes to Sweden’s environmental goals through
- reduced emissions of carbon dioxide when fossil components are burnt (limited climate impact)
- reduced creation of hazardous waste and risk of polluting land and groundwater when waste is stored and processed (poison-free environment)
- reduced creation of waste (good developed environment).
In this way, we also contribute to UN’s goals for sustainable consumption and production (Goal 12).
Interventions to reduce
APL is one of the actors in the Fossil Free Sweden initiative, and we have taken powerful charge of our own energy consumption to reduce carbon dioxide emissions. For example, we have initiated a detailed energy mapping of the company and installed separate meters to facilitate follow-up of our energy consumption.
Our employees and other stakeholders are our most important resources
A safe and secure workplace with healthy and creative employees increases delivery security, profitability and our chances of fulfilling the quality requirements. We are therefore working systematically on work environment issues in order to increase awareness throughout the company.
APL’s code of conduct
APL is working to ensure our suppliers operate according to the requirements and guidelines in our code of conduct. Follow-up is done via self-evaluation documents, and in some cases through inspections at our suppliers’.
The code of conduct is designed to minimise risks in the social area, and is based on ten principles according to UN’s fundamental declarations (on human rights, the rights of employees, environment and corruption).
It is APL’s ambition to show responsibility through sustainable business development.
Commitment that reinforces our sustainability work
We also do a lot to reinforce our social commitment in society:
- We contribute to organisations, such as Save the Children, Ung Cancer (Young Cancer) and the Swedish Childhood Cancer Foundation
- We participate in several networks, such as the Swedish Association for Sustainable Business (NMC) and Nätverket för Hållbart Företagande (the Swedish network for sustainable companies), to exchange experiences and develop skills within business.
- We are members of the sector organisation SwedenBIO, which works for a competitive life science sector in Sweden.
- We participate in SWElife, a national initiative to coordinate and develop stable research and innovation processes for Swedish life science.
- We are associates of UN’s Global Compact.
- We collaborate with universities so that degree projects can assist us in developing ideas that reinforce APL as a sustainable company, for example in how to increase knowledge about the environmental impact of medicines and correct collection of surplus medicines.
Sustainability work reported according to GRI
Every year, we report the outcome of our work on sustainable development. For the eighth year running, we are reporting the sustainability work according to Global Reporting Initiative’s (GRI) guidelines and, as from our financial year 2018, according to GRI SRS (Sustainability Reporting Standards), a global standard for sustainability reporting level Core.
The sustainability report complies with the guidelines for external reporting for companies with state ownership, and it is audited by a third party.
Read more in our Annual and Sustainability Report (in Swedish) Opens in new window.