Independent GMP Compliance Advisory for Pharma and Life Sciences

Readiness, Review and Recovery for GMP-Critical Systems and Projects

At the intersection of inspection readiness, validation, process control, data integrity, digital systems, engineering and GMP projects.

GMPCA is an independent GMP compliance advisory for the pharmaceutical and life sciences industries.

Our focus is on readiness, review and recovery for GMP-critical systems and projects — particularly where regulatory expectations, technical complexity and operational reality must be brought together in a credible and sustainable manner.

GMPCA supports organisations in situations where compliance must translate into action: in preparation for, support during and follow-up to audits and inspections, in validation- and quality-critical environments, in the context of data integrity and digital systems, and in engineering and project settings where structural weaknesses may become costly or carry regulatory significance. This also includes the structured remediation of weaknesses and the definition and implementation of improvement and optimisation measures.

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Expertise

  • QMS Design and Review
  • GMP Gap Analysis
  • Regulatory Readiness Assessment
  • Annex 1 and Contamination Control Readiness
  • Audit and Inspection Support

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  • Validation Strategy and Risk Framework
  • Validation Programs and Master Plans
  • Validation Lifecycle Management
  • Impact of Changes and Validation Control
  • Continued Process Verification (CPV)

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  • Risk Assessments for Data Integrity and Digital Systems
  • Implementation of ALCOA+
  • Data Integrity in the Design of Digital Systems
  • Data and System Monitoring
  • Readiness for Inspections of Data Integrity and Digital Systems

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  • GMP Design Reviews
  • URS Reviews
  • Engineering Risk Assessments
  • Commissioning and Qualification Strategies
  • Project Governance Reviews

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For GMP systems and projects requiring structure, resilience and effective implementation.

GMPCA Advisory Approach

A consistent four-phase approach across all areas of expertise

Evaluation

Clarification of the current situation and analysis of critical risks and structural gaps

Design

Development of an appropriate and risk-based solution

Implementation

Consistent execution and operational embedding of the defined solution

Oversight

Ensuring sustainable control, transparency and long-term robustness

Explore Our Approach

Independent Perspective.
Clear Accountability.

GMPCA combines independent GMP compliance advisory with 25 years of experience in regulated organisations and projects across the pharmaceutical and life sciences industries. The focus is on sound judgement, structural clarity and targeted support in situations where systems, projects and decisions must be robustly designed, reviewed or stabilised.

About the Founder