QUALITY FOR FACILITIES, PROJECTS AND PRODUCT DEVELOPMENT

We support pharmaceutical and biotech companies wherever quality is critical to achieving the next milestone

FACILITY AND SYSTEM QUALIFICATION

We support pharmaceutical facilities and systems from requirements definition through to operations.

  • Qualification strategies
  • Document management

  • URS and risk assessments (Requirements Engineering)

  • DQ, FAT/SAT, IQ, OQ and PQ with risk-based test planning

  • Traceability and final documentation, including transition to operations

CRITICAL PROJECT PHASES

When projects stall, quality issues escalate or a milestone is at risk, we provide rapid, hands-on support.

  • Qualification and documentation gaps, including gap analyses and missing or inconsistent evidence

  • Critical deviations and CAPAs

  • Interface issues and project stabilization prior to release or production start-up

  • Audit and inspection readiness

 

We assess the situation, prioritize the key risks and work with the project team to close the outstanding items.

INTERIM QUALITY ASSURANCE

We assume QA responsibilities for a defined period when internal capacity is limited or the organization is approaching a critical development milestone.

  • Temporary coverage of QA roles

  • Phase-appropriate development and stabilization of the QMS

  • Data integrity and data compliance

  • QA support for scale-up and technology transfer

 

We establish the quality structures required for the next milestone and ensure an orderly handover to the internal team.

Our Team

Ing. Philipp Weißenböck M.Sc.

Project Quality Manager / Managing Director
Experience: 10+ years

  • Yellow Belt Six Sigma & SCC
  • Plan, lead and execute DQ, FAT, SAT, IQ, OQ, PQ & reports 
  • Project Management
  • GMP Documentation Management
  • Expertise in cleanroom- / TCU- and equipment qualification

 

Martin F. Ortner

Project Quality Manager / Managing Director
Experience: 10+ years

  • Project Management, Qualification Strategy Expert & Troubleshooting
    • Track & Trace: from URS and Risk Assessments via DQ, IQ‑OQ‑PQ / TM to reports
  • Trainings in Lateral Leadership, CSV and Auditing
  • CPRE FL by IREB

 

Lukas Herrmann M.Sc.

Project Quality Engineer
Experience: in progress

  • basic understanding of Qualification Projects and GMP frameworks

 

Fa. GMP Doc GmbH

Buchenweg 4
A-3451 Streithofen
office@gmpdoc.at

UID: ATU79766139
Gerichtsstand: St. Pölten / NÖ
FB-Nr.: 610384z