Quality Control Labratory

Pharmaceutical Quality Control laboratory in Chemi Darou Company has acquired some labs as follows:

IPQC, chemical lab (classical analytical chemistry, instrumental analytical chemistry), and microbiological lab. It also includes documentation part, and all of the controls for raw materials and packaging, semi products and finished products is running here in this department.

Quality controls of raw materials and all products has been obtained from the valid instructions and from the medical references such as BP, EP, USP and in some cases using In-house methods. The above mentioned instructions should be controlled by medical quality control unit (classical analytical chemistry, instrumental analytical chemistry).

Controlling of environmental and microbial condition for production line, microbial control of water, raw materials, products and the determination of potency of vitamins and etc are managed by microbiological laboratory in Q.C.

In-process quality Control laboratory or IPQC is also supervising production and packaging department in order to be assured to run GMP roles during production from re-weighting to packaging.

Documentation unit in Pharmaceutical Quality Control laboratory has responsibility for standardization of method validation and process validation and updating them by the latest and the most modern resources.

Quality Control activities are as below:

Before providing raw materials and packing equipment required for production, Commercial department of Chemi Darou send samples which are forwarded by manufactures to QC department for controlling the evaluation of quality parameters. After controlling and approving the sample by our labs, the cargos are purchased by Commercial department.

Subsequent to dispatching the cargo to the factory and based on valid sampling instruction, some samples are taken from the cargo and it is sent to the chemical laboratory of medical control department and, if require to microbial labs.  The samples from the packing cargo is also analyzed and investigated in this department. After verifying the cargo, warehouse and planning unit make some programs for production.

During the production phases and regarding the nature of each process, quality control is done within the production. After running the production processes, some samples are taken from the finished product and all of the physical, chemical and microbial tests are performed on them.

Pharmaceutical Quality Control laboratory accept all the responsibility for evaluating new product. Based on this responsibility the first phase of producing industrial novel products is controlled by Pharmaceutical Quality Control laboratory, Research and Development department and Quality Assurance.

Running the periodical and stability testing is part of some other activities for Quality Control laboratory. These tests are run for over 3 batches of each product and followed up until the expiry date of the products and in some batches until 5 years.

Some other responsibilities of Pharmaceutical Quality Control laboratory is to control various environmental parameters such as temperature and humidity in warehouse or different of part of production line. The reports of above mentioned parameters are submitted to the responsible units.

The presence of expert and trained staffs is a very positive point for Quality Control laboratory. Thus, this unit is able to do the latest test based on latest valid medical versions.

Quality Control laboratory of Chemi Darou Company has been equipped with the most advanced equipment for all required tests. We can refer to seven devices such as 7 set of HPLC, 2 set of GC and one set of Atomic Absorption, a set of Liquid Particle Counter and one set of FTIR and etc.

Quality Control laboratory of Chemi Darou Pharmaceutical Company by exploiting of suitable space, advanced equipments and by enjoying of trained and expert personnel has been successful to get authorized DMF from the ministry of MOH and obtaining accredited medical labs from DGA of Germany.

One of the most important projects in Quality Control laboratory of Chemi Darou Company is to establish laboratories quality management system.

The establishment of this system needs the proper requires and wanting in laboratory in which most of the personnel has sufficient qualifications to do the test. These personnel are using the equipments and reports the valid results.

Starting the activity of Laboratories Quality Management Systems was only possible by employing of editing documentary in the same root of quality goals as well as the essential measures by Chemi Darou Co.

Some of the advantages of installing the quality management system is to use standards methods for testing, updating standards methods, paying attentions to personals qualifications in the lab and promoting them, improving the equipments and adapting them with testing methods. All of which lead to high quality of testing results and accepting our testing reports in a national and international references. Therefore, our lab is in the same route with the other qualified laboratories in the world.