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CLEANING VALIDATION SUPPORT

Pharmaceutical companies often struggle with Cross-Contamination Control and Cleaning Validation.


 
From our own experience Cross-Contamination Control and Cleaning Validation a topics that many pharmaceutical companies struggle with. This is confirmed when you have a look at the MHRA inspection deficiency data trending report: The EU GMP chapters (3.6, 5.20, 5.21, Annex 15/(10)) show the most combined critical and major observations made by MHRA inspectors.

The latest changes in EU GMP Chapter 5, 6 and Annex 15 introduced the risk based approach which required a rethinking of these processes:

  • We must no longer refer to products as high potency, cytotoxic, hormonal etc. but instead refer to their individual PDE values (toxicological values)
  • Alignment and segregation criteria must be backed up though risk analysis, encompassing the new criteria
  • Change in the calculation of cleaning limits, in relation to the API PDE (or ADE) values

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