Our Innovations
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SPC is ethically bound to the development of quality products apart from its legal obligations.
In doing so it has adopted SFDA, US-FDA, EU, PICs, WHO, ISO standards and in terms of current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), and International Conference for Harmonization (ICH) guidelines. Further it also develops its own standards to ensure that the products consistently meet the predefined standards.
Quality is embedded in every aspect of our business, and the way we support our internal and external customers. From product development, and through manufacture to distribution process, we ensure our quality standards are met.
SPC has developed and sustained a strong position in Saudi Arabia in terms of growth, serving export markets and a preferred partner in local and international alliances.
SPC plant utilizes state-of-the-art technologies in order to manufacture safe and effective high-quality medicinal products. Heavy investment in advanced machinery/technology has served in efficiency in product life cycle and supply-chain management.
SPC is committed to protect its employees as well as the environment. The company relies on the participation of all employees on the continuous improvement of the Quality, Health, Safety and Environmental Management System (QHSE).
SPC adapt Quality Management System (QMS) is focused on achieving quality policy and quality objectives to meet the regulatory and customer requirements. The QMS is being maintained and monitored using electronic record that improves the workflow within the quality system.
Enterprise Resource Planning (ERP) – SAP, streamline business application and provide a high degree of confidence on managing critical quality/GMP processes.
Quality Assurance unit in SPC, ensures that quality systems are implemented, maintained, followed and improved. Line inspection provides assurance that the manufactured products follow the pre-determined in-process specifications and comply with its standards. The environmental conditions are being monitored and qualified.
Validation is an integral part of the quality system wherein it provides documented evidence with a high degree of assurance that a process, method or system will consistently produce to the required specification in accordance with accepted standards of cGMP and local or international regulations.
Quality Control activities cover all measures taken into the product, including the setting of specifications, sampling, testing and analytical method to ensure that raw materials, intermediates, packaging materials and finished products comply with established specifications for identity, strength, purity and other characteristics.
Quality improvements are being accounted by undertaking good compliance program that assures strict adherence to the policies and principles of SPC Integrated Quality Management System.
Our Certifications
At Sudair Pharmaceuticals, we uphold the highest international standards in safety, quality, and environmental responsibility.
CERTIFICATE
GMP Compliance of a Manufacturer from the Saudi Food and Drug Authority (SFDA).
CERTIFICATE
GMP Compliance of a Manufacturer from (GCC).
ISO 9001
Quality Management Systems (QMS)
ISO 14001
Environmental Management Systems (EMS)
ISO 45001
Occupational Health and Safety management system