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Quality Assurance

Our experienced and knowledgeable professionals in quality and compliance have enabled successful outcomes to rigorous GMP and approval inspections by the Iranian Food and Drug Organization. Each department at Pooyesh Darou involved in GMP manufacturing maintains a quality program that meets its specific needs and is consistent with the guidelines provided in the our quality program. Pooyesh Darou QA team continuously monitors these programs to assess their effectiveness. Our QA team is also responsible for review, approval, and control of critical processing steps, component release, and documentation in support of GMP manufacturing.



Pooyesh Darou personnel, equipment and facilities are guided by exacting processes and procedures. Our production site meets and exceeds standards for ISO 9001:2008, ISO OHSAS, 18001:2007 and ISO 14001:2004.

Quality Systems

In addition to our outstanding credentials, we have the following systems in place to ensure quality:

  • Validation programs in place
  • Equipment qualifications IQ,OQ,PQ
  • Strict process controls
  • Master procedure documentation and control
  • Specifications development and management
  • Work flow control: receiving, production and shipping
  • Batch record development and documentation
  • Personnel training program – dedicated trainers
  • Robust in-process testing
  • Rigorous management of change control



In a regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations can have unpredictable and sometimes devastating results. Therefore, at Pooyesh Darou, we pay special attention to equipment qualification and process validation to provide full regulatory compliance. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure our products are of the highest quality when it reaches its destination.