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Quality Management System

 

The company believes in total quality management system and is constantly upgrading standards of specifications of its products. The quality policy states as under: The policy of Unique Pharmaceuticals Limited is to ensure that the quality of the products satisfies the safety, efficacy and other requirements of customer and society according to current good manufacturing and laboratory practices.


Quality has been the prime consideration in recruitment of manpower.


For further strengthening the system, following activities are carried out :


  • The In-house training program covers all relevant aspects of CGMP.

  • Control of input materials by testing them as per our well-defined specifications controls / control procedures. Like wise well defined specifications, test and release procedures are followed for semi finished and finished products exit. Production as well as Quality Assurance, monitors quality by carrying out in process testing and controls during various stages of manufacturing.

  • Standard operating procedures are available for different operations. Products are manufactured as per procedures given in batch manufacturing records and recorded accordingly.

  • Standard validation/calibration protocol is adhered to for validation of all critical equipments/processes/instruments.

  • Master formula records, which are prepared for individual products, are adhered to in batch manufacturing & testing processes.

  • Maintenance history records are maintained for critical instruments and equipments to ensure proper preventive maintenance.

  • The assessment of effectiveness of Quality management system is done by periodic self inspections covering all aspect of factory operations and most importantly :

  • Incoming material Quality

  • Product Quality

  • Compliance with systems / document control

  • Customer complaints

  • Corrective action to avoid non-conformity

  • Out of Specifications (OOS)

  • Internal Quality Audits

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