Regulations and documentation
The regulator includes all measures and solutions that continuously ensure the quality of the product and their compliance with the predetermined specifications, and then document the licenses of the Food and Drug Administration and submit them to the organization. Therefore, the quality assurance unit of Ashkan Zist Company will be in charge of performing good manufacturing operations (GMP) and will ensure proper management of production processes in the applicant companies will help them to continuously monitor all production processes and quality control. Improve and ensure quality continuity.
Establishing and implementing a comprehensive quality management system and obtaining the highest standards of the pharmaceutical industry for a continuous and effective presence in domestic and global markets in the field of product production is one of the main missions of the company to consult with applicant companies.
Services available:
Compilation and revision of management documents including organizational goals, strategies, production process plan, policy, regulations, SMF and…
Establishment of a comprehensive validation program (Validation Master Plan)
Completion and follow-up of pharmaceutical product files (CTD)
Supervise the observance and implementation of GMP, GLP, GSP principles
Quality Risk Management
• Supplier evaluation
• Obtaining GMP certification for all production lines
• Obtaining ISO 9001 2015 certification from the German company DQS
Obtaining ISO 13485 2016 certification from DQS Germany
• Obtaining a product production license
Obtaining Iran code for products
• Obtaining a company establishment license
• Obtaining operating licenses for various production lines of the company
• Company registration
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