Quality Assurance

Technical Assistant

The technical supervisor oversees the proper design and implementation of the pharmaceutical quality system, which includes optimal manufacturing conditions (GMP) and quality risk management, from all angles of the organization. Applying the supervision provided in the relevant instructions to ensure compliance with the methods. The equipment used in the production and control of the product has been used in such a way that the products are in accordance with the relevant standards and legal requirements in terms of safety, nature and quality, as well as guaranteeing the health and quality of the product until the end of the expiration date. And legal in case of health, health and quality problems in the product Technical Director is responsible. The managing director of the GMP committee and the technical director are the secretary of the committee. It should be noted that the technical manager in the field of technical affairs supervision of the factory, design of projects, compilation of technical and documentation instructions according to cGMP principles, drafting of technical contracts and projects, estimating the required credit for technical issues and projects, factory backup management It is also active.

Contact assistant

Quality Assurance

Quality assurance is a broad concept that encompasses all matters that alone or jointly affect product quality and must be planned, organized, directed, reviewed, and monitored to achieve the set goals. Achieving quality goals in the pharmaceutical company requires a quality management system. A system whose design is comprehensive and its implementation is done correctly. The quality management system includes quality assurance, GMP principles, quality control, and risk management. Quality management must be fully documented and its efficiency monitored. In the field of pharmaceutical quality, reflective quality is the observance and compliance with documentary rules and regulations such as the optimal method of production, analysis, storage, and distribution of pharmaceutical products, which is generally expressed in the form of the term GXP. Vira Vaccine Shaya Pharmaceutical Quality Management System is based on models proposed by reputable organizations such as OIE guidelines and Pharmaceutical Inspection Co-operation Scheme-PIC / S and International Council for Harmonization (ICH). The tasks of the quality assurance unit are:

Registration, Rules and Regulations

The organization ensures that there are strategies in place for accessing, classifying, communicating and updating the rules and regulations governing the quality management system.

Quality risk management (QRM)

Quality risk management is done to evaluate, control and review various risks with the quality of pharmaceutical products in the quality assurance unit.

Product quality review (PQR)

Periodic review of the company's entire products is done with the aim of validating the existing production methods and clarifying any quality process and identifying cases that can improve the products and processes.

GMP

The quality assurance unit covers all GMPs for production processes and quality control.

Calibration

All equipment is calibrated periodically to ensure the accuracy and precision of environmental measurements and monitoring,

Validation

Authorization is one of the basic pillars of GMP principles that in the quality assurance unit of Vira Vaccine Company, it is necessary to validate the processes and achieve the quality of systems and devices to achieve the goals of quality assurance.

Documentation Center

Documents required to be compiled in the quality management system are subject to the necessary controls. The quality records in the quality assurance unit of Vira Vaccine Company of Shaya have been approved, approved and reviewed and the original version of all documents is kept in this unit.

Education

Monitoring the training of GMP principles and work standards at the high evel, holding training courses for personnel and operators at the factory level and continuous communication with the research and development unit to solve production problems are always considered.

Store and Distribute

matching the physical specifications and packaging of warehouse items (raw materials, packaging) with standards and regulations, discharge of all raw materials, packaging products for consumption after approval by the laboratory of quality control and monitoring of material transfer from warehouse to Units ,providing suitable conditions for storage during transportation are among the responsibilities of the quality assurance unit.

Internal inspection and approval of suppliers

Writing an executive method for internal inspection, self-assessment of production processes and related parts periodically to determine their compliance with valid international principles and finally communicating the results of internal inspection to the relevant units to eliminate defects in the quality assurance unit.

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