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Case

Validation of packaging lines

Pharma company

Challenge

  • Large physical upgrading of packaging lines handling medical devices due to global requirements for serialization of packaging materials and products.
  • Support on all validation activities from site acceptance tests, risk assessments and requirement specifications to installation, operation and process qualification.
  • Completion and handling of change requests and actions/deadlines within.
  • 100 % onsite support for 12 months.

Solution - Proces

  • The project required a consultant 100 % allocated onsite with access to all relevant IT systems and packaging areas.

  • The project utilized SCRUM principles in order to perform daily board meetings.

  • Requirement specifications were completed in close collaboration with equipment responsible and validation responsible.

  • In some cases validation of a packaging line was performed, reviewed and approved electronically without any hardcopies involved.

Results

  • All consultancy work was completed onsite at the client and 100 % under the client’s QMS and procedures.
  • As several packaging lines were in scope of the validation, the consultancy work was planned as part of the SCRUM board meetings and allocated where most needed.
  • All validation activities including installation, operation and process validation were completed and approved.
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Michael Holt

Consultant
IT & Automation / GAMP, GMP, Facilities & Equipment Validation, Computer System Validation