project

Diagnosis for validation of cleaning processes for a pharmaceutical plant

Compliance / Security Life Sciences France

Context and challenges

This client is a company specialised in the development of X-Ray and MRI imaging solutions for diagnosing major diseases such as cancer, cardiovascular, inflammatory and neurodegenerative diseases.

For several years now, this client has undertaken a cleaning validation process. Following an observation made by Brazilian regulatory authorities, which are particularly stringent, this company sought to improve its cleaning validation process.

This client commissioned Assystem to conduct a diagnosis on the cleaning validation methodology implemented with respect to regulatory guidelines, and a state of the art of professional standards (strategic and practical approaches) for cleaning validation in general, and more specifically for implementation to their injectable production lines.

Project scope

  • Analysis of cleaning validation documents: validation plan, cleaning validation strategy, protocols, reports
  • Identification of deviations from regulatory requirements specific to cleaning validation and to best practices (coming from the literature on this topic as well as team feedback)
  • Identification of recommendations to solve any deviations observed and address the client’s specific questions

The diagnosis conducted covered the following items: justification of choice of contaminants, TOC (Total Organic Carbon) measurement versus specific method, rinsing water versus swabbing, calculation methods, expression of limits and specifications, sampling plans, and periodic validation.

Client benefits

  • Guaranteed worldwide product launch through regulatory evaluation conducted for the different international requirements: United States, European, ICH (International Council for Harmonisation), Canadian, Brazilian, Japanese, and WHO (World Health Organization)
  • Identification of specification to be adopted and optimal response to client requirements through the expression of specifications in different units
  • Improvement of strategic documents and practices through proposed recommendations based on regulations, literature and Assystem Care team feedback
  • Simplification of responses to questions arising in audits or inspections through the production of theme-based summary sheets

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