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Cleanliness is a state. Without evidence, it remains a claim.

X-Mon Germany GmbH
Deutsche Fassung

Projects

Typical projects, deliberately without client names.

Confidentiality is part of the job. The examples therefore show project type, scope and outcome. We leave out names, locations and figures.

Project type 01 anonymised

GMP documentation for a new build

New GMP-relevant building section with cleanroom areas, HVAC and utilities. Several trades, each supplier with its own documentation status.

Scope

  • Qualification master plan with objects and scope
  • Risk assessments as the basis for the URS
  • URS and traceability matrix for the GMP-relevant systems
  • Coordination with designers, suppliers and QA

Outcome

A continuous document chain in which every requirement is linked to a risk and to evidence.

  • QMP
  • Risk assessment
  • URS
  • Traceability

Project type 02 anonymised

Qualification of a cleanroom area

Newly built cleanroom area that had to be qualified before production started.

Scope

  • Room book as the basis for the DQ
  • Test plans and protocols for IQ, OQ and PQ
  • Witnessing tests and securing raw data
  • Deviation management and final reports

Outcome

Qualification documentation ready for approval, with deviations closed out traceably.

  • Cleanroom
  • Room book
  • DQ
  • IQ
  • OQ
  • PQ

Project type 03 anonymised

Annex 1 gap analysis

Existing manufacturing areas were to be assessed against the requirements of the revised EU GMP Annex 1.

Scope

  • Review of technical documentation and site walk-through
  • Assessment of cleanroom, HVAC and utility systems
  • Placement within the Contamination Control Strategy
  • Prioritised action plan

Outcome

A reliable picture of the current status and an agreed sequence of actions.

  • Annex 1
  • Gap analysis
  • CCS

Project type 04 anonymised

Extension of compressed air and HVAC systems

Extension of existing compressed air and ventilation systems affecting GMP-relevant areas.

Scope

  • Assessment of the requalification scope in change control
  • Update of risk assessment, URS and test plans
  • Witnessing tests
  • Updating traceability

Outcome

Qualified systems with documentation that matches the modified status.

  • Compressed air
  • HVAC
  • Change control

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