A company’s quality policy is a formal declaration by the  management that sets forth the company’s basic principles, objectives and obligations to ensure and improve the quality of products or services. The quality policy (German translation: Qualitätspolitik) aims to define standards and procedures that ensure that products and services comply with legal requirements, customer expectations and the applicable GMP standards in the pharmaceutical industry.

The most important elements of a quality policy:

• Commitment of the company: The quality policy reflects the company’s commitment to complying with quality standards such as GMP or ISO 9001 as well as other legal requirements. It expresses the manufacturer’s efforts to continuously improve its products and processes.
• Quality objectives: The document sets clear goals that the company aims to achieve in order to maintain and improve product quality. These quality objectives include, for example, reducing the reject rate in production, optimizing processes, ensuring the safety of manufactured drugs (German translation: Arzneimittel) and meeting customer needs.
• Role and responsibility of staff: The quality policy emphasizes the importance of involving all employees in quality assurance (translation into German: Qualitätssicherung) as well as the need for ongoing staff training.
• Monitoring and quality improvement: The quality policy includes the obligation to regularly monitor, analyze and improve the pharmaceutical quality system (German: pharmazeutisches Qualitätssystem) in order to promote product stability and safety of.

The importance of the quality policy:

• A reference point for all employees: The quality policy helps employees at all levels of the company to understand their tasks and objectives within the framework of the general quality strategy.
• Compliance with regulations: A company’s quality policy helps the company to comply with national and international regulations as well as product quality and safety requirements.
• Strengthening customer trust: A quality policy that has been carefully thought out strengthens the company’s image on the market, ensures customer loyalty and creates trust in the company’s products.

The quality policy is therefore a fundamental component of a company’s quality system, ensuring compliance with high standards and the continuous improvement of the quality of the products and services offered.

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