Infrastructure | Quality Testing

 

Quality control department functions as per Standard Operating Procedures (SOPs) by which all its activities are governed. The sampling and testing of starting materials - raw and packaging materials, the in-process materials like blends and granules and the finished products in the packaged form; all these activities are carried out by the authorized Quality Control Chemists as per approved specifications. Each batch undergoes individual sampling and testing prior to approval / rejection. The dispatch of finished goods for sale / distribution can be planned only after authorization for Release upon approval by Quality Control department.


TESTING PROCEDURE:

The raw material, packaging components, semi finished goods and the finished products are sampled as per SOP. These items are analyzed by Standard Test Procedures and approved on compliance to specifications. SOPs, Specifications and Test Methods constitute the documents controlled, issued and used by the Quality Control Department for the sampling, testing and approval of materials and products.


The methods of analysis used by Quality Control Department cover physical and chemical testing, instrumental analysis by sophisticated electronic instruments like:


1. High Pressure Liquid Chromatograph (HPLC)

2. FTIR

3. Gas Chromatograph (GC)

4. Microbiological testing for total bacterial count, fungal count and absence of pathogens.

5. UV / Visible Spectrophotometer

6. And other all the modern facilities required by in a Lab.


The test results are documented and preserved as Certificate of Analysis with the raw data, as per statutory requirements up to one year beyond the expiry of finished products.


The batch history is recorded in the BPCR - Batch Production and Control Records, from its issue till the packaging and dispatch of the finished goods. Each BPCR is issued to Production department by Quality Assurance and is reviewed during dispensing, manufacturing, packaging and during the release of the finished product. Certificate of analysis is prepared on completion of testing of finished product and enclosed in the BPCR by Quality Control Department.


Specifications for raw materials, packaging components, in-process items and finished products are prepared by Quality Control Department, approved and controlled by Quality Assurance Department. SOPs are prepared by the respective departments, reviewed, approved and are controlled by the Quality Assurance department.


The Batch Production and Control Records (BPCR) are prepared by the Production Department based on the transfer of technology from R&D department to the manufacturing unit. These are reviewed, controlled and issued by Quality Assurance Department. Master documents are preserved in the Quality Assurance Department.

 

Infrastructure

 
Corporate Office  
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Factory Setup  
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Quality Testing  
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Machinery  
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