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Industrial Area

Review, development and implementation of SOPs

  • Pharmaceutical laboratories, manufacturers and importers, must have a technical report in accordance with Spanish Royal Decree 824/2010 of 25 June.  
  • The regulatory authorities carry out inspections of Good Manufacturing Practices and Good Distribution Practices, so the Quality System documentation must be kept up to date.  
  • An adequate documentation constitutes a fundamental part of the Quality Assurance system and is fundamental to work in compliance with the requirements of the GMP/GDP  
  • At Azierta, we review, develop and implement standard operating procedures (SOPs) in a clear and concise manner on the GMP-related activities of pharmaceutical laboratories. In addition, we provide support in the development and revision of the Technical Report and the Quality Manual of the plants.  

Review, development and implementation of documentation Support

  • Standard Operating Procedures (SOPs)  
  • Quality Manual  
  • Technical report  
  1. Preparation of the document  
  2. Review of the document  
  3. Approval of the document  

At Azierta, we are specialists in GMP quality systems, and we guarantee their effectiveness, tracking and implementation.

Quality system services 

  1. GxP support
  2. GMP/GDP Certification
  3. GMP Compliance Adviser 
  4. Medicinal Cannabis Consultancy

Advice and implementation of quality systems

  1. Audits and/or inspections
  2. Review, development and implementation of documentation
  3. Validations - implant support
  4. Quality risk management (ICH Q9)





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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