ZISTDARU DANESH COMPANY(ZDD CO.)
ZDD Co. pharmaceutical production plant comprises the following departments in compliance with GMP principles.
A.Production lines of pharmaceutical products
- Production line of pharmaceutical recombinant proteins in the prokaryote host
Introduction:This complete line( biotechnology of recombinant DNA)deals with the production of an effective protein drug starting from the engineered cell(manipulation of gene expression) in the prokaryote host cells.
Equipment and capability:Conducting the process of fermentation, conducting the process of purifying recombinant proteins using advanced chromatography equipment and utilizing ultrafiltration,storage and distribution of biological materials are among the capabilities of this department.
- Production line of complex biomolecules such as antibodies in the eukaryote host
Introduction:This line deals with the production of complex biomolecules,such as monoclonal antibodies,by using eukaryotic host animal cells.
Equipment and capability:Conducting culture media using a bioreactor to express the target protein, purification and removal of viral contamination and post-translational reform processes are among the capabilities of this department.
- Production line of injection vials
Introduction:This line produces the final product as an injectable vial in the formulation,filling and lyophilization section.
Equipment and capability:The production of injection vials in aseptic conditions is among capabilities of this section.
- Production line of solid oral products
Introduction:This line deals with the production of final products in the form of oral tablets and capsules.
Equipment and capability:Using the containment system in the production of potent products and simultaneous protection of the environment and manpower is among the capabilities of this section.
B.Quality Control Laboratories
Introduction:Quality control labs carry out precise tests on raw materials,packaging materials,materials produced during production(byproducts),final product and samples of sustainability studies.
Equipment and capability:Using the most equipped and the most up-to-date equipment and performing tests in accordance with the principles of optimal laboratory and ensuring the quality,efficacy and safety of pharmaceutical products is among capabilities of this section.
C.Quality Assurance Department
Introduction:Quality assurance is a process-oriented approach whose main purpose is to prevent defect in the product in the planning stage in order to avoid revising and the expenses therein.ZDD Co. quality assurance dept. emphasizes on planning,documentation and implementation of the guidelines that are necessary for quality assurance.This process(quality assurance) starts at the beginning of the project so that the prerequisites and the requirements of the product from the very beginning of the project are identified and in accordance with guidelines and national and international laws and regulations are resolved.
Tools in the dept. of quality assurance that relies on trained personnel with specific knowledge and skills are as follows:
1.Quality management system(review of non-conformities, control of changes, corrective and preventive measures).
2.Approvals of equipment quality and validations of methods
3.Process analysis(in the process analysis, trends to find improvements, root causes of problems and identification of surplus and valueless activities are analyzed).
4.Identification,assessment and control of the quality risks(risks affecting the quality of products as well as the risks of cross contamination based on QRM protocol are identified,evaluated and controlled).
5.Periodic inspections(an effective tool to ensure that the best of approved practices and procedures are utilized).
The control tools in quality management include statistical quality control techniques,multi-criteria decision making science(MCDM) and so on.
In addition to the above mentioned points,the quality system of pharmaceutical products(PQS) runs based on the company approach to the legal requirements of the Food and Drug Administration of Iran(IFDA) and the guidelines of WHO,PIC/S,FDA,EU as well as the quality management system ISO9001,and to achieve a product free of any flaws and defects based on a program compiled under the title of VSM(Validation of Systems and Methods) is in operation at all levels.
It is imperative to observe the principles of the integrated system of quality by all employees in order to move towards effective management and we are committed to comply with the following:
- customer satisfaction through increasing product quality
- increasing the efficiency and efficacy of the employees performance
- increasing safety for employees, processes and manufacturing facilities
- strengthening and consolidating the position of the company in the domestic and foreign markets
- improving environmental protection and prevention of pollution
- providing appropriate conditions in accordance with the laws and regulations governing the activities of the company
- upgrading GMP status in accordance with the national requirements of the country