Quality Assurance

The quality of the Groups bulk pharmaceuticals and Laboratory Chemicals can be attributable to its stringent quality control. Our company has formulated and implemented a comprehensive Quality Assurance System.

a) Quality control on the production process:
1) Active ingredient testing
2) Online production testing
3) Finished product test

b) Quality assurance is carried out in three main system areas:
1) Internal audit system
2) Quality compliant disposal system
3) Drug recall process system.

Quality Control System

In ensuring the uniform quality of our Laboratory Chemicals and Pharmaceutical raw materials, each batch we produce is stringently tested; every single parameter must correspond precisely to the defined specifications. Testing takes place in our own Analytical Laboratories using complex testing procedure. Those products that have one or more pharmacopoeia specifications are specifically tested to ensure that they fully correspond to the latest valid version. The products are released only when our quality control confirms this. The test procedures and methods we use and the specified limits involved have monograph character and may be requested by customers.

The analytical values established during testing of a particular batch can be provided on request in the form of a Batch Analysis Certificate. In many cases this can be used for ISO 9001:2000 documentation purposes; the user can hence reduce his own testing of incoming goods.

If our pharmaceutical raw materials are used in the manufacture of solutions for injection or infusion the manufacturer is obliged to observe the special regulations specified by the relevant pharmacopoeias. According these regulations once the solution has prepared, it must be filtered and sterilized and , if necessary, subjected to pyrogen or endotoxin
testing.

Our Quality Control Laboratory is well equipped with sophisticated instruments viz.,
GC, HPLC, Spectrophotometer, IR, Atomic Absorption, Karl-Fischer, Polarimeter etc.

For further information write to info@gmpct.com