Our Projects

QP-ENG übernimmt Ihre Projekte von der Planung über die Qualifizierung bis hin zur Messtechnik.

QP Engineering Team gesamt

Our Projects

QP-Engineering handles your projects from planning through qualification to measurement technology.

QP Engineering Pharmazeutische Wasseraufbereitungsanlagen

FDA Readiness Project

  • GAP analysis of media systems (Purified Water, WFD water, pure steam, compressed air)

  • P&ID walkdown against installed equipment

  • Aligning USP regulatory requirements with current Ph. Eur. test procedures

  • Execution of requalifications

QP Engineering Reinraum-Messtechnik Testprotokoll Simon Menges

Qualification Project

  • Restructuring of a qualification department (introducing processes, creating valid SOPs)

  • Scoping and execution of qualifications and requalifications

  • Commissioning and initial qualification of an airlock

QP Engineering Pharmazeutische Wasseraufbereitungsanlagen

FDA Audit Project

  • Validation of an optical inspection system for medical devices

  • Development of validation strategy, test methods, project plans, and validation documentation

QP Engineering Reinraum-Messtechnik Messgerät Simon Menges

Automation Project

  • Development of automation concepts for laboratory equipment

  • Creation of documentation (FDS, HDS, SDS, IT administrator SOPs)

  • Support during commissioning

QP Engineering Reinraum-Messtechnik Testprotokoll Simon Menges

Qualification Project

  • Qualification of packaging equipment and other systems in line with current standards

  • Creation of qualification documentation (URS, RISK, DQ, IQ, OQ, PQ)

  • Validation of new products on packaging lines

QP Engineering Pharmazeutische Wasseraufbereitungsanlagen

Commissioning Project

  • Commissioning and testing of an assembly line for medical devices

  • Creation of qualification documentation (flowcharts, schedules, traceability matrix, IQ, OQ, PQ)

  • Project lead for commissioning and test execution

Cleanroom Monitoring Projects

  • Creation of qualification plans and reports

  • Execution of the following measurements:

    • HEPA filter integrity test
    • Recovery time test
    • Determination of air exchange rates
    • Determination of temperature and humidity
    • Airborne particle measurement
    • Airborne microbial measurement
    • Smoke studies

Temperature distribution measurement

  • Temperature mapping of ultra-low temperature freezers and standard freezers

  • Temperature ranges from +50°C to -80°C

  • Creation of qualification plans and reports

  • Measurement data analysis as well as cold and hot spot determination

GMP Laboratory Process Optimization

  • Management of quality systems with training and CAPA processes

  • Development and maintenance of SOPs and qualifications

  • Execution of impact assessments and FMEAs

  • Creation of risk analyses and reviews

Building Management System (BMS) in a GMP Environment

  • Creation of monitoring and URS documentation

  • Supplier selection and installation supervision

  • Execution of qualifications and Computer System Validation (CSV)

  • Reporting and archiving

Maintenance Management System (MMS)

  • Definition and documentation of all maintenance processes

  • Software selection and equipment inventory

  • Creation of URS and risk analyses

  • Development and execution of CSV validation

Decommissioning of GMP Production Facilities

  • Development of the qualification strategy and documentation

  • Execution of final qualifications

  • Cleanroom measurements and equipment verification

  • Creation of final documentation and archiving

QP Engineering Pharmazeutische Wasseraufbereitungsanlagen

FDA Readiness Project

  • GAP- Analysis von Medienanlagen (AP-Wasser, WFD-Wasser, Reinstdampf, Druckluft)

  • P&ID walkdown against installed equipment

  • Aligning USP regulatory requirements with current Ph. Eur. test procedures

  • Execution of requalifications

QP Engineering Reinraum-Messtechnik Testprotokoll Simon Menges

Qualification Project

  • Restructuring of a qualification department (introducing processes, creating valid SOPs)

  • Scoping and execution of qualifications and requalifications

  • Commissioning and initial qualification of an airlock

QP Engineering Pharmazeutische Wasseraufbereitungsanlagen

FDA Audit Project

  • Validation of an optical inspection system for medical devices

  • Erstellung von Validierungsstrategie
    und Testmethodenent-
    wicklung,
    Projektplänen, Validierungsdokumen-ten

QP Engineering Reinraum-Messtechnik Messgerät Simon Menges

Automation Project

  • Development of automation concepts for laboratory equipment

  • Creation of documentation (FDS, HDS, SDS, IT administrator SOPs)

  • Support during commissioning

QP Engineering Reinraum-Messtechnik Testprotokoll Simon Menges

Qualification Project

  • Qualification of packaging equipment and other systems in line with current standards

  • Creation of qualification documentation (URS, RISK, DQ, IQ, OQ, PQ)

  • Validation of new products on packaging lines

QP Engineering Pharmazeutische Wasseraufbereitungsanlagen

Commissioning Project

  • Commissioning and testing of an assembly line for medical devices

  • Creation of qualification documentation (flowcharts, schedules, traceability matrix, IQ, OQ, PQ)

  • Project lead for commissioning and test execution

Cleanroom Monitoring Projects

  • Creation of qualification plans and reports

  • Execution of the following measurements:

    • HEPA filter integrity test
    • Recovery time test
    • Determination of air exchange rates
    • Determination of temperature and humidity
    • Airborne particle measurement
    • Airborne microbial measurement
    • Smoke studies

Temperatur- verteilungsmessung

  • Temperature mapping of ultra-low temperature freezers and standard freezers

  • Temperaturbereiche von +50°C bis -70°C

  • Creation of qualification plans and reports

  • Messdatenanalyse sowie Cold- und Hotspot Berstimmung