GMP Consulting, Audits & Training

Structured consulting, audits, and training for regulated environments.

Services & Areas of Support

This page provides an overview of GMP consultancy, audit, and training services offered to organizations operating in regulated environments.

All services are performed in a structured and documented manner.
Where applicable, activities are concluded with clear, traceable, and audit-relevant written reports supporting internal follow-up and regulatory readiness.

All engagements are structured to enable sustainable internal execution and clear accountability beyond the consulting period.

GMP Consulting

Structured GMP consulting focused on regulatory clarity, risk awareness, and practical implementation within regulated environments.

Scope includes:

  • interpretation of applicable GMP requirements

  • assessment of existing quality system frameworks

  • identification of compliance risks and weaknesses

  • pragmatic recommendations aligned with regulatory expectations

Consulting activities can be summarized in written assessments or reports where appropriate.

GMP Status Assessment / Gap Analysis

Objective evaluation of the current GMP compliance status to establish a realistic and transparent baseline.

Scope includes:

  • review of documentation, processes, and quality systems

  • identification of gaps against applicable regulatory requirements

  • prioritization of findings based on regulatory relevance

  • structured basis for corrective and preventive planning

The assessment is concluded with a structured written report summarizing findings and recommendations.

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Third-Party GMP Audits

Independent audits of suppliers, service providers, and partners conducted from an external and neutral perspective.

Scope includes:

  • supplier and contract manufacturer audits

  • GMP, GDP, and GACP audits

  • audits of pharmaceutical, medical device, and cannabis-related operations

  • assessment of data integrity practices and controls

  • audit execution with focus on relevance, objectivity, and clarity

  • structured audit reports with actionable findings

Reporting approach:

Each audit is concluded with a structured audit report.
A draft version of the report is first provided to the client for review.
One round of factual clarification is included prior to finalization.
The final report is then issued to both the auditee and the client (if requested by client).

(This area represents a core focus based on extensive audit experience.)

Mock Audits & Inspection Readiness

Realistic simulation of regulatory inspections to prepare organizations for authority audits and inspections.

Scope includes:

  • inspection-like assessment of systems and documentation

  • identification of potential findings and compliance gaps

  • review of audit behavior and organizational preparedness

  • practical feedback aligned with inspection expectations

Mock audits are concluded with a structured report reflecting observations, potential findings, and improvement opportunities.

Documentation Creation & Review

Support in the creation, review, and structuring of GMP documentation aligned with regulatory expectations.

Scope includes:

  • SOPs and controlled procedures

  • quality manuals and site master files

  • validation-related documentation

  • role-specific and process-oriented documentation

  • all QMS related documents, methods, protocols and forms

Documentation activities result in controlled, traceable documents aligned with regulatory expectations.

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Training & Knowledge Transfer

Practical GMP training designed to strengthen understanding, awareness, and regulatory confidence across organizations.

Scope includes:

  • GMP fundamentals and advanced topics

  • inspection preparation and audit behavior

  • data integrity and documentation practices

  • role-specific training for QA, operations, and management

Training sessions may be accompanied by written summaries or training documentation where required.

Training services are part of the broader GMP service portfolio.

Professional Exchange

If you would like to discuss your current GMP status, audit readiness, or specific compliance topics, an initial professional exchange is possible.

Clarify scope and engagement approach.

Request an Initial Discussion