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Annex 1: Manufacturing of sterile products

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  • Annex 1: Manufacturing of sterile products
Implementation
Evaluation
Design
Documentation
Post-authorisation
GMP Smart Writers
  • Azierta can provide support in complying with the new Annex 1 requirements. Our team of professionals has extensive experience in this field, so we offer a global, competitive and dynamic service tailored to the client's needs.
  • At Azierta we ensure compliance with Annex 1 regulations. We have extensive experience and a long track record in regulatory services, which is why we can offer a competitive and dynamic service with the best quality guarantees.

- Find out about our Annex 1 services -

Support on the implementation of GMP Annex 1 requirements

  • Advice on regulatory requirements
 
 
  • Implementation strategies for corrective and preventive actions (CAPA) resulting from risk assessment
 
 
  • Plant and process design (monitoring systems, preventive maintenance…)
 
 
  • Audits and compliance assessments

Risk assessment and process validation

  • Review and optimisation of existing processes
 
  • Generation of protocols and validation reports
 
  • Periodic review of risk management for continuous improvement of quality control (preventive maintenance)
 
  • Evaluation of sterility test non-conformities and deviations from environmental control or established processes

Design and optimisation of facilities

 
  • Implementation of monitoring systems

  • Implementation of environmental control systems

  • Review of environmental monitoring systems

Documentation of procedures required for Annex 1

  • Standard Operating Procedures (SOP)
 
 
  • Approval of suppliers
 
 
  • Manufacturing records
 
 
  • Implementation of environmental control systems

Training on GMP controls of the specific requirements of Annex 1

  • Training workshops on annex 1 (hygiene, clothing, etc.).
 
  • Specific training for quality control managers.

GMP Smart Writers

  • Qualified implants in charge of the preparation and review of the necessary documentation
 
  • Implementation of SOPs

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