project

Remediation plan for two production sites of active pharmaceutical ingredients

Compliance Life Sciences China

Context and challenges

This client is an integrated global player in pharmaceutical synthesis and specialty ingredients. This group has two production sites in Asia Bangpoo (Thailand, 20 km from Bangkok), Wuxi (China, 250 km from Shanghai) which are involved in the production of an Active Pharmaceutical Ingredient (API) in dry form (paracetamol, aspirin).

Following a Warning Letter from the FDA, the group had to implement a remediation plan, particularly for the cleaning and cleaning validation processes.

This client called on Assystem Care to define and implement a remediation plan for the cleaning scope of the two Asian production sites.

Project scope

  • Performing a gap analysis on the "Cleaning and Validation" processes of the cleaning activity: approach, documentation, practices
  • Drafting of a remediation plan including the definition and formalization of “cleaning and validation” strategies for cleaning for each piece of equipment (drafting of master cleaning documents):
    • Standardization and securisation of cleaning practices at the two sites
    • Implementation of the cleaning validation strategy
    • Establishment of sampling methods
    • Implementation of control systems for cleaning validation (sampling, analysis method, etc.)
    • Drafting of validation plans and validation protocols
    • Coordination of activities
  • Implementation of the remediation plan with the completion of the first cleaning validation runs
  • Collaboration with local management and operational staff as well as staff from the Lyon headquarters (13 work trips made in Asia)
  • Training of local teams in cleaning, validation of cleaning and to pursue initiated activities
  • Animation of companionship to practices related to cleaning and its validation

Client benefits

  • Increasing in staff skills on cleaning methods and validation of cleaning according to the functions of each
  • Improving and homogenizing of cleaning thanks to implementing good practices (documentation, critical parameters) / tools (pistols, pipes, enclosures)
  • Controlling the results of "cleaning validation" thanks to improving strategy definition (tracers, grouping, worst-case, acceptance criteria, sampling plan) and practices (sampling, analysis, documentation, periodic verification)

En chiffres

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groups of equipment

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masters procedures

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protocols

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training sessions

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