Quality in SPIMACO
Quality beyond Compliance
SPIMACO ADDWAEIH recognizes its responsibility towards meeting customer requirements and satisfaction by applying quality criteria in all business aspects within the organization. Furthermore, SPIMACO 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.
Qassim Plant is the main pharmaceutical manufacturing site of SPIMACO ADDWAEIH. It 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.
SPIMACO ADDWAEIH 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). Click here to review QHSE Policy
SPIMACO 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.
• Manufacturing Execution System (MES), it covers all areas related to specification, manufacturing, quality assurance, and process optimization. The system is benefiting in accelerating the time of batch release, improved process quality just in time and maintaining the master batch record.
• Laboratory Information Management System (LIMS) is an integral part of SPIMACO Quality systems that manages electronic data. It enhances the pace of workflow in order to organize effective data management and has benefited the laboratory processes. The LIMS system improved productivity without sacrificing data integrity and accuracy by increasing throughput, thus reducing errors.
Quality Assurance unit in SPIMACO, 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. The water system is qualified to assure compliance with the regulations and standards.
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 final 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 SPIMACO Integrated Quality Management System.
SPIMACO ADDWAEIH has been awarded with the following certification:
1. Certificate of GMP Compliance of a Manufacturer from the Saudi FDA.
2. Certificate for ISO 9001( Quality Management System), ISO 14001( Environmental Management System) and OHSAS 18001(Occupational Health and Safety Management System)
3. Certificate of Environmental Conformity from the Presidency of Meteorology and Environment (PME) KSA.
4. GCC Award for the best manufacturing facility.
5. King Abdul Aziz's award for the best plant in the Chemical Industry
6. Prince Naif Award for Saudization (1st rank) in the health Sector.
7. GMP Compliance Certificate from Romanian Health Authorities
8. GMP Compliance Certificate from Health Products Regulatory Authority (HPRA)