The pharmaceutical production plant of Zistaroo Danesh Company includes the following parts in accordance with GMP principles:

A- Production lines of pharmaceutical products

Production line of pharmaceutical recombinant proteins in prokaryotic hosts
Introduction: This complete line (recombinant DNA biotechnology) produces an active protein drug starting from an engineered cell bank (prokaryotic host).Equipment and Capability: Fermentation process, purification process of recombinant proteins using advanced chromatographic equipment and operation of various ultrafiltration systems and storage and distribution of biological materials are the capabilities of this department.

• Production line of complex biomolecules such as antibodies in eukaryotic hostsIntroduction: This line produces complex biomolecules such as monoclonal antibodies (monoclonal antibodies) using animal cells (host eukaryotes).

Equipment and Capability: Performing culture processes using bioreactors, target protein expression, purification and removal of viral contaminants and post-translational modification processes are some of the capabilities of this department.

• Injection vial production lineIntroduction: This line produces the final product in the form of injection vials in the formulation, filling and lyophilization sections.

Equipment and Capability: Production of injection vials in aseptic conditions is one of the capabilities of this department.

• Production line of solid food productsIntroduction: This line produces the final product in the form of tablets and oral capsules.

Equipment and Capability: The use of the Containment system in the production of potent pharmaceutical products and the simultaneous protection of the environment and human resources are among the capabilities of this sector.

• Quality control laboratories

Introduction: Quality control laboratories perform detailed tests on raw materials, packaging materials, materials produced during the process, the final product and samples of stability studies.

• Quality Assurance Department Introduction: Quality assurance is a process-oriented approach whose main purpose is to prevent product defects in the planning stage to avoid rework and the resulting costs.The Quality Assurance Department of Biodrug Danesh Company emphasizes the planning, preparation of documents and implementation of guidelines that are necessary to ensure quality. This process (quality assurance) begins at the beginning of the project to identify the requirements and needs of the product from the beginning of the project and address them in accordance with national and international guidelines and laws.
• Capabilities: The tools that are used in the quality assurance department by relying on trained personnel and with special knowledge and skills are
• Quality management system (check for non-compliance / change control / corrective and preventive measures)
• Quality assurance of equipment and validation of methods
• Process analysis (in process analysis, trends to find improvements, root causes of problems and Identify redundant and worthless activities are analyzed.)
• Identification, evaluation and control of quality risks (risks affecting product quality as well as risks related to cross-contamination (Cross-contamination) are identified, evaluated and controlled according to the QRM protocol.
• Periodic inspections (an effective tool to ensure that best practices and Approved instructions are used.) Control tools in quality management include statistical quality control techniques, multi-criteria decision science (MCDM) and..In addition to the above, PQS (Pharmaceutical Product Quality System) is based on the company’s approach to the legal requirements of the Food and Drug Administration (IFDA) and The guidelines of PIC / S, WHO, FDA, EU as well as ISO 9001 quality management system have been established and in order to achieve a product free from any defects and defects according to the program called Validation of Systems and Methods (VSM) at all current levels. .Adherence to the principles of an integrated quality system by all employees is necessary to move towards effective management And we are committed to the following:
• Satisfying customers by increasing product quality
• Increase the efficiency and effectiveness of staff activities
• Increase employee safety, production processes and facilities
• Strengthening and stabilizing the company’s position in domestic and foreign markets
• Improve environmental protection and pollution prevention
• Providing appropriate conditions by observing the laws and regulations governing the company’s activities
• Upgrading the GMP status according to the national needs of the country