Achieving quality goals in a pharmaceutical company requires a quality management system. A system whose design is comprehensive and implemented in accordance with the requirements of the Legislative Assembly on this day. This system meets the requirements of ICH Q7,8,9 & 10, PIC / s including quality assurance, GMP principles, quality control and management Risk is Quality assurance is a broad-ranging concept. Quality assurance covers all the measures and solutions that alone or jointly can affect the quality of the product. Total quality assurance and all the measures and procedures used to ensure the quality of the product continuously and uniformly in accordance with predetermined and desired specifications. Quality management is not a coincidence and it is the responsibility of all people involved in the manufacture of pharmaceutical products. Quality management should be fully documented and monitored. For this reason, Alborz Pharmaceutical Company has been working to establish and monitor processes with the active participation of all managers and personnel involved in the processes with the leadership of the senior management of the organization. This system includes the organizational structure, methods, processes, resources, as well as activities for the assurance and trust that all products are in accordance with their specifications, which are determined on the basis of international requirements, prepared, manufactured, packaged and end-user-supplied Quality assurance will further establish a systematic process for identifying, assessing and managing potential and existing risks to protect the business and maintain the quality of the products, and, in order to meet the requirements and requirements, continuously It has been developed.
This unit ensures that production processes are properly managed throughout the life cycle, and that optimum conditions are taken into account. Calibration, validation, technical inspections and maintenance of quality systems are among the main tasks of this unit.
1. Calibration: The major part of the calibration of the equipment related to the pressure, temperature, humidity, volume, mass and dimensions are stipulated in the calibration laboratory of the company and according to the instructions in accordance with the national and international requirements.
2. Validation and Quality Validation: Qualifications of devices and processes are the responsibility of this unit as part of the implementation of GXP.
3. Technical inspections: In accordance with the instructions of the international legislature and the checklist approved by the Food and Drug Administration, inspections are carried out from all units of the company in a timely manner and take corrective, preventive and effective measures. Actions are being taken. Additionally, implementation of the QRM and APQR Quality Management System has been implemented.
4. Maintenance of quality systems: The company is committed to obtaining and extending valid domestic and international certificates by producing quality products.