Quality Control Department

Main responsibilities:

• Sampling ,testing of all materials
• Stability studies
• Monitoring of environmental conditions

All these operations are complied with standard operating procedures, validated methods and qualified equipment to guarantee the GLP requirements and national/international regulations.

• The Quality control Departments contains seven laboratories
• and one Sample Reception office

1. Sample Reception office
2. Raw Material lab
3. Physical Chemistry Lab
4. Microbiology Lab
5. Bioassay Lab
6. Molecular and Cellular Biology Lab
7. Animal Testing Lab
8. Chromatography Lab

The functions of the above sections include these items:

         Sample Reception:

3. Received samples based on submission rules, Recorded and admission code will be installed and distribute to related laboratory.
4. Provide certificate of analysis for each product and release it to quality assurance after final approval.
5. Prepare stability timetable for each product.
6. Making report of all tests done in quality control.
7. Preparing SOPs determined the number of samples for each test.
8. Admission of samples and provide professional services according to demand.
9. Control samples are transferred to the warehouse for dry or cold products. So if necessary will be sent to the requesting unit.

           Raw Materials Lab:

• Testing of packaging and raw materials.
• Determination of chemical elements by atomic absorption spectroscopy.
• Determination of impurities.
• Identification by FTIR Spectrometry.
• Testing of Water for injection, purified water, soft water and also waste water.

            Physical Chemistry Lab:

Conducting all tests based on the latest edition of pharmaceutical pharmacopoeias like BP, USP. Physical and chemical quality control of final and intermediates products and also in process samples included:

• Organoleptic characteristics.
• Particle Counting.
• Determination of pH, melting point, heavy metal, protein conc., nitrogen content, moisture, lipid, carbohydrate and excipient.

              Microbiology Lab:

• Preparation and testing of culture media.
• Promotion, sterility and mycoplasma tests.
• Determination of microbial limit.
• Microbial control of raw materials, waters and products.
• Efficacy test of sanitizing agents and preservatives.
• Preparation and control of microbial banks.
• Environmental monitoring.

        Bioassay Lab:

• Testing of bacterial antigens and antiserums.
• LAL test (Gel clot, Chromogenic).
• Elisa test for recombinant protein and protein impurity concentration.
• Potency determination (In vivo, In vitro).
• Oxygen uptake of BCG products.

               Molecular & Cellular Biology Lab:

•    Cell culture techniques. 
•    Preparation, control and cryopreservation of recombinant microbial and
     cell banks.
•    Cytotoxicity test.
•    Flow cytometry analysis.
•    Determination of biological activity of recombinant proteins.
•    Determination of host cell DNA contamination.

   Identification by PCR