Pharmaceutical Quality Control Laboratory
Pharmaceutical Quality Control laboratories in Chemi Darou Company has some labs include:
- IPQC , Chemical lab (classical analytical chemistry, instrumental analytical chemistry), Microbiological lab and Documentation part. All of the controls for raw materials, packaging materials, semi-finished products, and finished products are running here in this department.
- Quality controls of raw materials and products is based on valid working instructions of pharmaceutical references such as BP, EP, USP and in some cases In-house methods.
- Controlling the environmental and microbial condition for production department, microbial control of water, raw materials, products and determination of potency of vitamins and some other materials perform by microbiological laboratory in Q.C.
- In-process Quality Control laboratory or IPQC is supervising production and packaging department in order to be assured to run GMP rules during production from re-weighing raw materials to packaging finished products.
- Documentation unit of Q.C. laboratory provide SOP’s, WI, COA of raw materials, packaging materials and products. This unit also update items mentioned above according to the latest version of pharmaceutical references.In addition, providing some sectionts of new drugs CTD and export documents are parts of this unit duties.
Quality Control Laboratory Activities:
- Before providing raw materials and packaging materials required for production, commercial department send samples of different manufacturers to Q.C. laboratory for controlling evaluation of quality parameters. After analyzing and approving a sample, commercial department purchase the cargo.
- After transferring the cargo to the factory Q.C. staff take some samples based on valid sampling instruction. They transfer samples to the chemical laboratory and microbial laboratory, if it is required. After Q.C. laboratory verify the cargo, warehouse and planning department make some plans for production.
- During production steps, In-process control has been done regarding to pharmaceutical dosage forms. After finishing production process, some samples are taken from the finished products, and all of the physical, chemical, and microbial tests are performed on them.
- Quality Control laboratories is responsible for controlling parameters of new products based on valid references or received analysis method from R&D department. Based on this procedure, scale up of new drugs controlled by Q.C. laboratory, R&D department, and Q.A. department.
- One of the other activities of Q.C. laboratory is controlling of retained sample of all products. These tests perform on at least three batches of each product and it will continue one year after expiring date of product.
- The presence of expert and trained staff is the strength of Chemi Darou Company Q.C. laboratories. These staff can help the laboratory to do all tests according to the latest version of pharmacopeia.
- Q.C. laboratories of Chemi Darou Company has been equipped with the most advanced equipment for all requiring tests including:
1) 7 sets of HPLC
2) 2 sets of GC
3) 1 set of Atomic Absorption
4) 1 set of Liquid Particle Counter
5) 1 set of FTIR
6) 1 set of Polarograph
7) 1 set TOC Meter and ……
- Pharmaceutcal Q.C. laboratories of Chemi Darou Company by exploiting of suitable space, advanced equipment, and expert staff gain Accreditation Certificate from the ministry of health (MOH). This laboratory is known for allowed pharmaceutical laboratories.