Quality certifications

Doppel Farmaceutici Srl is approved by AIFA, the Korea FDA, ANVISA, China FDA, the US FDA, and the Republic of Kenya’s Ministry of Health. It is certified ISO 13485 to manufacture medical devices.

ISO 9001, ISO 22001, and IFS certifications are available for the food department.

All products comply with Good Manufacturing Practices (GMPs) during the manufacturing process, and the plants are authorized by the respective local and non-European regulatory bodies.
All personnel engaged in GMP and product-quality and safety monitoring procedures receive training on topics related to Good Manufacturing Practices, as well as periodic updates on the various procedures.

The Company’s commitment to quality is laid out in the following Quality Assurance Principles:

  • Doppel is committed to working closely with its Customers, helping them attain their goals. Doppel endeavours to help them succeed and strives to be a partner earnestly and professionally committed to seeing its customers progress with their products through to completion: from formulation to marketing and post-marketing. Doppel strives to support its Customers with their choices, innovations and projects, offering a wide range of services

  • Quality Assurance comprises all the measures intended to achieve this goal, considering customer needs, regulatory requirements, the environment, the state of the art, and the Company’s standards.

  • Quality is a corporate obligation and shared responsibility of all associates. Because manufacturing and using pharmaceutical products entail certain risks, an effective Quality Risk Management approach must be implemented to identify, assess, and control them, guaranteeing pharmaceutical product quality throughout the entire “life cycle”. All managers are responsible for informing team members of their roles and responsibilities how authority is delegated within the system, and ensuring interactions are well defined and understood.

The Quality Departments’ duties and responsibilities include:

  • Developing and implementing quality strategies and related policies to ensure worldwide product quality and regulatory compliance;

  • Overseeing the implementation of all measures necessary throughout the Company’s line functions;

  • Maintaining contact with Customers and ensuring that local operations comply with local regulatory requirements;

  • Providing or organizing technical and managerial support to operational units;

  • Providing general, technical and regulatory information;

  • Coordinating product recalls.

Doppel works on a contract basis and develops manufacturing for Italian and International Generic and Branded Pharmaceutical Companies. For this reason, customers and regulatory authorities regularly inspect its sites to ensure high quality and safety standards.