> Quality Assurance
Quality Assurance

GenIbet has an experienced Quality Assurance Unit that is able to provide the guidance and support to all aspects of GenIbet operations and functions, ensuring all GenIbet operations conform to current GMP and regulatory guidance.

These include quality expertise in the following aspects of Quality Assurance:
      - GMPs – advice related to manufacture of biotechnology products, manufacturing, 
      stability, etc. 
      - Regulatory requirements – guidance on biotechnology products ranging from 
      developmental products up to (and including) stability 
      - GMP Documentation and Records – providing comprehensive, clear and 
      traceable documentation and records to meet current GMPs and regulatory 
      submission 
      - Quality Management Systems – providing a robust yet simple Quality 
      Management System that conforms to current GMP 
      - Validation – expertise in validation and qualification of systems, equipment, 
      processes, computer systems (to 21 CFR part 11), utilities, facilities, cleaning

GenIbet is approved by INFARMED (Portuguese regulatory authority) according to the “Certificate of GMP Compliance of a Manufacturer” and is working with them for approval of the new GenIbet facilities.

GenIbet Quality Assurance provides a clear and simple solution of the ever changing requirements of the Biopharmaceutical Industry.

 
 
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