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Proecess Validation

 
   Products :
Tablets, Capsules (Beta lactam and non beta lactam antibiotic) ointments & external lotion products are manufactured at this facility. There are four types of products:
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Process validation is a documented program, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

We follow the following system with regard to process Validation:
i)   Establish specifications and performance criteria.
ii)  Select methodology, process & equipment to ensure the product meets the specification.
iii) Test the final product using validated analytical methods in order to meet specification.

Following steps supports the above steps:
i)    Calibration, verification and maintenance of process equipments.
ii)   Qualification of both process & equipment.
iii)  Challenge, audit, monitor or sample the recognized critical or key steps in the process.
iv) And finally when there is a significant change in the product or Process.  Re-qualify or       revalidate the process

 

 
 

 

 
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  • Details of QC lab
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  • Qualification arrangement for equipments
  • Calibration
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