QA/QC

QA/QC

QA/QC

We strive to provide customers with quality products that exceed their expectations. We achieve this through our Quality Assurance program developed to ensure continuous validation and improvement in all areas of the manufacturing process.

The depth of experience, capabilities, knowledge of our technical professionals and advanced scientific analytical instruments ensures that a world-class quality of final product reaches our customers.

One of our Directors, Dr. Ulhas Ganu, himself heads this department which follows current Good Laboratory Practices (cGLP), in total quality management. Achieving this standard is a step towards the systematic and documented work culture that we follow.

The analytical skills of our experienced and qualified Quality Assurance and Quality Control team are supported by Sophisticated Analytical Instruments. Stringent in-process quality checks are conducted at each entry and exit level of raw material and the packing material. Regular Validation of facilities, equipment, process, products & cleaning as per respective standard operating procedures are carried out at regular intervals. Other activities include Complaint Handling, Storage of quality record and control samples, conducting and maintaining Stability Studies, and preparing of Registration Documents (DMF) in accordance with the respective FDA regulations.

 

Quality Assurance Department’s span of responsibility includes the following activities:

Validation 

  • Preparation of validation plans for facility / equipments / process, including cleaning.
  • Approval of protocols for validation of facility / equipment / product / process.   
  • Team member for execution of validation of facility / equipment / product / process.
  •  

Documentation Control   

  • Controlled distribution and archiving of documents.   
  • Control of changes made by proper change control procedure.   
  • Approval of all documents.
  •  

Quality Improvement Plans   

  • Feedback received from the compliance team   
  • Proposals for corrective & preventive actions   
  • Annual products review
  •  

Assuring Quality of Products   

  • cGMP training   
  • SOP compliance   
  • Audit of facility for compliance   
  • In-process counter checks   
  • Critical sampling   
  • Record verification   
  • Release of batch for marketing   
  • Investigation of market complaints   
  • Stability of products
  •  

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