Quality Control

Quality control laboratories with dedicated and dexterous staff are able to perform all tests in compliance with the latest version of pharmacopoeia and guidelines. Likewise our Laboratory management system is based on GLP regulations & standard ISO 17025: 2005.

1: Raw Materials Laboratory
The lab is accredited by Ministry of Health and Medical Education and awarded in 2014 from MOH. In this laboratory all of experiments regarding approval of pharmaceutical raw materials and packaging material have been carried out. In addition, Identification of each container of every consignment is made beside its approval test. The lab is equipped with the HPLC systems, GC, Karl Fischer, IR and other equipment and materials needed to perform the tests.

2: Microbial Laboratory
Culture media preparation & incubation in this laboratory are equipped with dedicated clean rooms. Microbial tests are performed on all raw materials and stages of intermediate products as well as finished product. In purposes of validations and verification, tests are applied on samples from production areas and machinery. The lab has two autoclave, incubator, colony counter and also media types and microbial strains which are needed based on international standards.

3: Stability Laboratory
It has been one of the best equipped laboratories in our factory for monitoring the stability of our products in the long term and Accelerated condition and also retained sample. Chemical and physical tests for the approval of the stability of products have been conducted up to 1 year after the expiry date on the schedule in accordance with the standards rules.

4: Water laboratory:
This laboratory by using various systems will carry out experiments on potable water and all produced purified waters in the company as well as waste water before and after treatment according to international references. These tests consist of measuring conductivity, TDS, pH, hardness, heavy metals, TOC, anionic and cationic compounds and BOD/COD analysis.

5: Production Laboratory:
In purpose of approval of chemical and physical specifications, all products (liquids and solids) are tested in intermediate and finished stages according to international references and intended specification. In case of approval by this lab, the products might pass out the production stage. Tests performed by the laboratory include all the physical tests such as hardness, disintegration time, diameter and thickness, pH, viscosity, osmolarity, density and physicochemical tests such as uniformity of dosage forms contents, dissolution tests and assays.

6: In- Process quality control laboratory (IPQC):
In this laboratory all intermediate products according to defined specification for avoidance of any deviation during production frequently tested and evaluated. Tests are performed depending on the product type. The various products are sampled and tested every 5 to 15 minutes. The samples are taken from mixing, granulation, tablet process, capsule filing, blistering, cartoning, tablet coating, and mixing and Filing of drops.

Copyright © 2024 Bakhtar Bioshimi Co, All rights reserved.