Quality Policy
Issued On: 08/05/2023
Raspa is a biopharmaceutical company that focuses on the industrial manufacture of niche APIs (Active Pharmaceutical Ingredients) in the oncology and immunology therapeutic segments. It aims to reduce the cost of manufacturing of these APIs by half or more through technological innovation, automation, and process optimization; in line with the company’s goal to make healthcare more affordable, accessible, and sustainable.
At the forefront of the company’s mission and vision is its commitment to quality. At Raspa, we believe that high-quality products are essential to improving patient outcomes and reducing the cost of treatment. Therefore, we adhere to stringent quality management systems that are designed to ensure compliance with regulatory requirements and industry standards. Moreover, we continuously monitor and improve our processes to ensure that our products are of the highest quality and that they consistently meet or exceed customer expectations.
Raspa’s Quality Policy is guided by the following principles:
Stakeholder focus: We strive to understand and meet the needs of all our stakeholders including patients, healthcare providers, international and local regulatory authorities, customers, and any other interested third party.
Science-based Quality Systems: We apply a systematic approach to managing our processes to ensure that they are efficient, effective, and compliant with regulatory requirements and industry standards.
Creating a Quality Culture: We are committed to fostering a culture of quality and innovation, and to providing the resources and support needed to achieve our quality goals.
Continuous improvement: We continuously monitor and improve our processes and products to ensure that they meet or exceed customer expectations and regulatory requirements.
Within the framework of the Quality Management System and its quality tools, Raspa’s Quality Policy has been drafted to meet the following objectives:
i)
To establish, execute, and maintain a Quality System that allows the development and production of products with required quality attributes that meet the needs of all stakeholders and complies with the requirements of regulatory authorities, including the requirements of Marketing Authorizations, as applicable.
ii)
To establish and maintain proper control plans to ensure process adequacy to consistently produce the established quality of the products.
iii)
To facilitate the continuous improvement of Quality Management processes and systems to consistently meet the needs and requirements that the pharmaceutical field demands.
iv)
To establish quality risk assessment plans to ensure the achievement of the quality objectives pursued.
v)
To promote a culture of quality where quality systems are backed by scientific knowledge and reasoning.
To achieve these objectives, we have the following Action Plan:
1)
The quality systems will be duly established for both internal and external activities and products.
2)
The design, organization, and documentation of the Quality System will be clear and well structured, so as to facilitate a consistent and continuous application and traceability of activities.
3)
The Quality System developed in the Quality Manual will be based on compliance with Local and International Regulations of the geographical areas where the company wants to establish its presence for development and manufacturing of Active Pharmaceutical Ingredients.
4)
As a fundamental element of the Quality System, senior management has the ultimate responsibility to ensure that an effective pharmaceutical quality system is in place to achieve the quality objectives, and to ensure that roles, responsibilities, and authorities related to quality compliance are defined, communicated and implemented throughout the company.
5)
The execution and management of the Quality System will be the responsibility of the Quality Head, who will report to the Chief Executive Officer (CEO). The necessary degree of independence will be given to the Quality Head to exercise his/her functions.