QUALITY ASSURANCE

This department focuses on:

  • Establishing Quality standards, Upgrading Quality Systems as per cGMP, GLP and ICH standards
  • Prepare, revise and implement Standard Operating Procedures.
  • Prepare “Site Master File” , Qualification & Validation (facility, equipment, analytical methods and process validation) and update it as and when necessary.
  • Training personnel on quality aspects across various departments in the organization
  • Conducting internal audits as part of self inspection program to ensure compliance of GMP standards and also conduct vendor audit.
  • Supervise manufacturing operations right from dispensing of raw materials / packing materials to completion of the batch.
  • Conducting Quality Reviews (APQR).
  • Change control, deviation investigation and handling of market complaints.
  • Preparing specification for RM, intermediates, in-process analysis and finished products and their test methods, making CTD (technical document) etc… as per sop’s and customer requirement.
  • Generate data (through testing by Q.C Lab) for all products regarding its stability.