Production, 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
Building
1200
m2
Expertises
- GMP Annexe 1 et 15
- ICH Q9
Challenges
- Qualité : 5/5
- Coût : 4/5
- Délais : 3/5
- Sécurité : 3/5
Services provided
- Contaminants and tracers to look for
- Calculation of acceptance limits according to the PDE approach
- Sampling methods
- Sampling plans
- Analytical methods coupled with sampling
- Master Validation Plan
- Protocols/VN reports
- Performance of the tests
Insight
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