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Quality Assurance & Security

The respect of the requirements

Traceability, documentary Control, Audits, Control, Qualification,Validation.

LYOFAL complies with the ISO 9001 frame, 2008 certificate and with cGMP standards and APIs requirements.

- LYOFAL has a Quality service which, according to the reference frame ISO 9001, 2000 certificate, guarantees the quality of the product, the organization and the documentary control and the uninterrupted improvement of the functioning system.

- LYOFAL freeze-dries active materials of pharmaceutical use (bulk), APIs (Active Pharmaceutical Ingredients) in a workshop according to ICHQ7A Guidelines or cGMP.

Attached to the Quality Assurance service :

- The Quality control Department controls raw material provided by the customer, the follow-up of the freeze-drying process, the control and the release of the freeze-dried products and inspects the buildings in order to guarantee an environmental quality.

- The Qualification and Validation Department is responsible for the setting up and the follow-up of the qualification of the buildings, the equipments, the control of the processes and the validation processes.

This service also meets your audits requirements and welcomes you at LYOFAL.

The Quality Department controls :

  • Raw material received from the client,
  • Freeze drying procedures,
  • Controlled release of freeze dried products
  • Production area in order to garanty an environmental quality.

The Qualification and Validation Department controls:

  • Clean rooms qualification,
  • Equipment qualification,
  • Monitoring of validation processes and procedures

Security :

  • surveillance 24h/24

  • independent surveillance contractor

  • training and fire exercises in place

  • Automated freezing cycle in case of electricity breakdown.



 





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