Code of Conduct

1. Introduction

As business activity of Iris Biotech GmbH impacts people’s lives and health, it must be operated in ethical and correct manner and act with integrity and responsibility. To ensure high ethical standards and fair business practices, Iris Biotech GmbH applies an integrated policy known as its Code of Conduct.

In 2001 Iris Biotech GmbH was founded just at the beginning of the Biotech movement and the first remarkable breakthrough of biotech pharma products. Although the biotech field is rather young compared to other industries we believe on long-term business, a good partnership between our business partners and Iris Biotech GmbH and a good reputation. It is our duty as well as our responsibility to maintain and to extend this over the next generations – based on the principles of an honourable and prudent tradesman which based upon the concept of honourable entrepreneurship.

This Code of Conduct has been developed following the “Voluntary Guidelines for Manufacturers of Fine Chemical Intermediates and Active Ingredients” issued by AIME (Agrochemical & Intermediates Manufacturers in Europe) and the requirements of some of our business associates.

Iris Biotech GmbH commits to hold this Code of Conduct and to include and apply its principles in the management system and the company policies.

2. Ethics

• Iris Biotech GmbH undertakes business in an ethical manner and acts with integrity. All corruption, extortion and embezzlement are prohibited. We do not pay or accept bribes or participate in other illegal inducements in business or government relationships.
• We conduct our business in compliance with all applicable anti-trust laws.
• Employees are encouraged to report concerns or illegal activities in the workplace, without threat of reprisal, intimidation or harassment.

3. Labour

• Iris Biotech GmbH is committed to uphold the human rights of workers and to treat them with dignity and respect.
• Child labour, workplace harassment, discrimination, and harsh and inhumane treatment are prohibited.
• Iris Biotech GmbH respect the rights of the employees to associate freely, join or not join labour unions, seek representation and join workers’ councils.
• Employees are paid and their working timetable is established according to applicable wage and labour laws.
• Employees are able to communicate openly with management regarding working conditions without threat of reprisal, intimidation or harassment.

4. General Policies

• Contracts and Secrecy Agreements are binding and the confidential information received is only used for intended purposes.
• Clear management and organizational structures exist to provide efficient normal working and to address problems quickly.
• Know-how is protected and intellectual property is respected.

5. Health and Safety

• Iris Biotech GmbH provides a safe and healthy working environment to the employees and protects them from overexposure to chemical and physical hazards.
• Products are produced, stored and shipped under the guidelines of the relevant chemical and safety legislation.
• Risks and emergency scenarios are identified and evaluated, and their possible impact is minimized by implementing emergency plans and written procedures. Safety information regarding hazardous materials is available to educate, train and protect workers from hazards.
• Preventive equipment and facilities maintenance is performed at suitable periods to reduce potential hazards.
• Employees are regularly trained in health and safety matters and are informed about product properties and risk classification when it is required.

6. Environment

• Iris Biotech GmbH operates in an environmentally responsible and efficient manner, minimizing adverse impacts on the environment.
• Waste streams are managed to ensure a safe handling, movement, storage, recycling and reuse, before and after being generated.
• Systems to prevent and mitigate accidental spills and releases to the environment are in place.
• All required environmental permits and licenses are obtained and their operational and reporting requirements are complied with.

7. Production and Quality Management

• A quality management system following the Good Distribution Practices (GDP rules) of Active Pharmaceutical Ingredients is established covering all the aspects of the worldwide distribution of products.
• Regular audits are performed to evaluate the efficiency and fulfilling of the quality system.
• Process controls to provide reproducible product quality are established.
• There are preventive maintenance procedures to ensure plant reliability and the lowest risk of failure.
• Staff is trained periodically about GMP and GDP rules.
• Procedures are established and installations are designed to avoid cross contamination.
• Batch and analytical records are kept for inspection and audit purposes for suitable periods according guidelines.

8. Research and Development

• Research and development staff education is appropriate to their functional activity and they are trained to develop, optimize and scale-up the processes. Intellectual property is respected and know-how protected.
• Development of manufacturing processes reflects the principles of the Green Chemistry according the American Chemical Society Green Chemistry Institute.
• Animal testing is not used unless alternatives are not scientifically valid or accepted by regulators. If animal testing is carried out, animals are treated so that pain and stress are minimized.