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Validations - implant support

Manufacturers must control their operations through product and process qualification and validation, as required by the GMP.  

At Azierta, through the support of implants, we can carry out validations in order to comply with the quality standards of each company and guarantee the quality of the medicines.

Azierta Validations Support – Support Through Implants

Our experts are constantly updated on Quality Management, Good Manufacturing Standards and Risk Management.

Procedure validations 

  • Risk analysis management, if applicable.  
  • Preparation of the validation protocol.  
  • Compilation of results.  
  • Preparation of the validation report.   

Cleaning validations   

  • Optimization of equipment and room cleaning.  
  • Confirm the effectiveness of any cleaning procedure.  
  • Global support in cleaning validations, from the study, rationalization, documentation to the implementation of new periods between the cleaning of equipment and rooms.

Azierta Methodology

  1. Evaluation of cleaning validations performed and status   
  2. Critical evaluation of rooms and equipment  
  3. Work plan proposal  
  4. Documentation (change controls, protocols, risk analysis, SOP changes...)   
  5. Execution of the defined sampling plan  
  6. Preparation of the final report and closure of change control  

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 2,000 clients

9 year experience

10 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

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