GxP-compliant processes, facilities and systems - QPRI - Transparency for Project Efficiency

Achieve, maintain and optimise GxP-compliant processes, equipment and systems

Comprehensive consulting and support services are provided for manufacturers of active pharmaceutical ingredients and medicinal products in the following areas:

Assessment of computerized systems with regard to qualification status, validation status including data integrity

Analysis of the maturity level with regard to data governance and data integrity

Further development of existing quality management systems / frameworks for the validation of computerized systems with regard to Good Engineering Practices (GEP), Data Integrity (DI ) and Data Governance (DG)

GxP-compliant management systems
Support for the GxP-compliant introduction, reorganization, optimization and integration of effective and efficient quality, project, risk and information security management systems compliant with EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines, ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System, U. S. Food and Drug Administration 21 CFR 210/211, 21 CFR 11
and GAMP^® 5, ISO 9001, ISO 27001/27005.

The organizational principles of High Reliability Organizations (HRO) are taken into account in order to further develop and optimise existing management systems:

1. HRO principle: Preoccupation with Failure

2. HRO principle: Reluctance to Simplify

3. HRO principle: Sensitivity to Operations

4. HRO principle: Commitment to Resilience

5. HRO principle: Deference to Expertise

Furthermore, I personally make sure that you regulate as much as necessary and as little as possible formally! Take me at my word! You can constantly challenge me with the question: “Where is the regulatory requirement that stipulates that we have to establish this regulation?”

I can provide you with optimal support in the following GxP areas:

Good Project Management Practice (GPMP)

Good Engineering Practice (GEP)

Good Automated Manufacturing Practice (GAMP)

Good Manufacturing Practice (GMP)

Good Documentation Practice (GDP)

Good Laboratory Practice (GLP)

GxP-compliant processes, facilities and systems

Audit & development of suppliers and service providers (internal & external)

Support with inspection preparations

Quality assessments & gap analyses

Documentation reviews

Validation of complex computerized systems and system networks

Validation / verification of complex computerized system networks, e.g.
PLC <=> DCS <=> (LIMS / BDIS / MES) <=> ERP
PEA <=> POL

IT infrastructure qualification: differentiation of IT infrastructure, global versus local IT organization, networks, servers, end devices

Data and systems migration: Procedure, verification, validation

Electronic (production) documentation: electronic data, electronic signatures, electronic approvals, electronic production records

Document life cycle: project and as-built documentation, specifications, user requirements, requirement and functional specifications, function and design specifications

Software development: conventions, tools, source code review, source code handling, Excel® validation

Test strategies: system environments, test steps, test types, test tools

IT security: physical / logical security

Operation and maintenance: service level agreements, periodic review of validation status, decommissioning

Deviation management / deviation processing: root cause analysis, definition of measures and corresponding CAPAs (Corrective and Preventive Actions)

Change management: classification, change management tools, re-qualification, re-validation

Emergency management:r isk assessment, organizational measures, emergency procedures to maintain system operation

Data backup / restoration (back up / restore)

Archiving / retransfer

and much more

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