Case
Validation of packaging lines
Pharma company
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
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The project required a consultant 100 % allocated onsite with access to all relevant IT systems and packaging areas.
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The project utilized SCRUM principles in order to perform daily board meetings.
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Requirement specifications were completed in close collaboration with equipment responsible and validation responsible.
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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
Seniorkonsulent, Projektleder & Kvalitetsansvarlig
IT & Automation / GAMP, GMP, Facilities & Equipment Validation, Computer System Validation
