Quality assurance and control
At Sami Saz Pharmaceutical Company, quality is the key issue that needs to be addressed, and for this reason, many regulations are important and must be followed.
In order to achieve such a goal, a quality management system that encompasses all relevant company units and personnel is essential. At Sami Saz Pharmaceutical Company, various functions related to quality management and the relationship between them are considered important. Quality management, QA, GMP and QC are interrelated, where quality management is at the forefront of quality implementation. It is then the Quality Assurance Unit (QA) that monitors the performance of the operating units and the operation of the devices and the quality of the product, as well as ensuring that GMP rules and standards are properly followed. The necessary arrangements and mechanisms for the manufacture of products, supply of raw materials and use of raw materials and proper packaging are done in the quality assurance unit. GMP is part of QA that assures us that the products are produced without defects and in accordance with quality standards. And are reviewed and controlled in accordance with their intended use and with the approval of the competent authority.
In Sami Saz Pharmaceutical Company, quality assurance unit includes:
- Continuous training of personnel
- Product clearance includes reviewing the entire manufacturing process of a product, reviewing all the results of a quality control laboratory in relation to the relevant product, and finally confirming the documents related to the production of a product. In the clearance process, after ensuring the accuracy of the production documents, the product approval for leaving the company is given to the technical manager and after the approval of the relevant technical manager, it is sent to the warehouse and connected to the manufactured product.
- Documentation and validation: Authorization of devices and processes
- Calibration: Equipment related to pressure quantities, temperature, humidity, volume, mass and dimensions is evaluated in the company’s calibration laboratory and based on written instructions.
- Handle customer complaints and review suggestions
- Internal inspections based on international guidelines and checklists approved by the Food and Drug Administration, Professional Health, ISOs
The pharmaceutical quality management system available in Sami Saz Pharmaceutical Company is based on the models proposed by reputable organizations.
In order to ensure the quality and health of the products, Quality Control Laboratories (QC) perform physical-chemical and biological tests using the most equipped and modern devices. The quality control unit is managed by skilled specialists in the fields of physicochemical control, microbial control and biological control.
Some of the devices in the chemistry laboratory of Sami Saz Pharmaceutical Company include three Dissolution devices, two Spectophotometers, one IR device, four HPLC devices and one GC and other laboratory equipment.
The quality control process has started since the arrival of raw materials in the company and has been continuously present during all stages of manufacturing, production, packaging and storage as a supervisor of product quality maintenance. After the presence of the product in the market, the quality control unit of Sami Sazhati Pharmaceutical Company is following the issues related to the quality and safety of its products.