QHSES & Compliance Validation of cleaning processes

Project

Supporting our client in the implementation of the strategy and the validation process of the cleaning processes for a biotechnological bulk production unit.

  • General methodology
  • Analysis of US and European standards
  • Implementation of a strategy for rational validation with maximum return on investment (optimisation of methods, groupings, “worst cases”, special products, etc.): presentation of typical matrices
  • Accompaniment on the follow-up of the maintenance in validated state

Challenges

  • Quality : 5/5
  • Cost : 4/5
  • Deadlines : 3/5
  • Security : 3/5

Services provided

  • Definition of the strategy and organisation of the steering of the validation;
    • Contaminants and tracers to look for
    • Calculation of acceptance limits according to the PDE approach
    • Sampling methods
    • Sampling plans
    • Analytical methods coupled with sampling
  • Writing :
    • Master Validation Plan
    • Protocols/VN reports
    • Performance of the tests

Summary

Bulk building 1200 m²

Expertise

GMP Annex 1 and 15

ICH Q9

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