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Quality risk management (ICH Q9)

Quality risk evaluation and assessment of medicinal products for human and veterinary use according to ICH Q9 guideline.  

The quality of the medicinal product should be maintained throughout the product life cycle.  

An Effective quality risk management is essential to ensure an efficient quality system. It guarantees:  

  1. High quality of the medicinal product.  
  2. Identifies and controls potential problems during development and manufacturing.  
  3. Improves the decision-making process if a quality problem arises. 
  4. Regarding regulatory authorities, it provides greater assurance of a laboratory's ability to deal with potential risks.  

Our services include:

  • Supplier management  
  • Planning of cleaning validations  
  • Prevention of Cross-Contamination  

At Azierta, we implement and maintain Quality Systems according to the needs of each company to improve the management of resources and results. 

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

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