GMP/GLP Audits of control laboratories

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laboratorioAudits will be perform according to GMP and GLP EU regulation for both physiochemical or microbiological control laboratories including those related to the control analysis and quality control of raw materials or end products.

 

In audits to control labs, implementation of data integrity procedures regarding generated data in the control laboratory will be checked.

Benefits:
  • Auditors with accredited experience in control laboratories
  • Review of data integrity compliance
  • Tailor made Audits
  • CAPAS follow-up until closure

Audits Process:

Information collection

To obtain the required information for the audit:

  • New provider or follow-up audit
  • In case of a new provider: development of a questionnaire to collect information prior to the audit
  • Technical agreement in effect
  • Specifications and Analytical Method
  • Historic (batches, complaints, …)
  • Additional information

Planning and Execution

Steps:

  • Date and agenda setting
  • Audit execution
  • Audit Summary: provided one week after the audit
  • o Final report writing. An initial draft is reviewed with the client to establish the significance of the observations and explain the audit development, this draft will be sent prior to 15 days to the client
  • Once accepted, the final report is sent to the client prior to 1 month, along with an audit summary with observations and conclusions

Seguimiento

Tras el envío del informe final se realizarían los siguientes pasos:

  • Envío al proveedor de un resumen de las observaciones
  • Se acuerda con el proveedor las CAPAs a realizar
  • Seguimiento periódico de las CAPAS hasta su cierre

 

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