Independent GMP Consulting & Auditing
Practical. Regulatory-focused. Audit-experienced.
The goal is a GMP system that works reliably without the consultant.
GMP Environment
GMP-regulated organizations operate under constant regulatory pressure.
Audits, inspections, documentation requirements, and training obligations must be managed consistently and transparently.
In daily practice, limited resources, increasing complexity, and legacy structures often make this challenging.
Common GMP Challenges
Many GMP issues do not arise from a lack of rules.
They arise from:
insufficient visibility of the current GMP status
gaps between documented procedures and daily practice
incomplete or outdated documentation
limited audit preparedness
lack of independent assessment
In such situations, external support is often required — not to replace internal responsibility, but to provide clarity, structure, and an objective view.
Sustainable GMP means the system remains stable and inspection-ready after external support has ended.
The objective is to strengthen internal ownership, decision-making and day-to-day execution — not to create dependency.
Services & Areas of Support
Support is provided across the full range of GMP activities, including:
GMP Consulting
General GMP advisory support tailored to the organization’s regulatory context.Mock Audits & Readiness Assessments
Structured preparation for regulatory inspections and internal audits.GMP Status Assessment (Gap Analysis)
Objective evaluation of the current GMP compliance status.Documentation Support
Creation, review, and structuring of GMP documentation in line with regulatory expectations.Third-Party GMP Audits
Independent supplier, contract manufacturer, and service provider audits
(with a strong focus on audit execution and audit-relevant findings)GMP Training & Knowledge Transfer
Practical training sessions for GMP personnel, QA, and management.
Each engagement is adapted to the specific regulatory environment and conducted with a clear audit perspective.
Audit Experience
The work is based on more than 30 years of experience in GMP-regulated environments.
Audit experience exists from both perspectives:
as an external GMP auditor
and as an audited organization (auditee)
This dual perspective allows a realistic understanding of:
how audits are prepared
how findings are generated and assessed
how expectations are communicated by auditors
and how organizations experience audits internally
The focus is therefore not only on regulatory requirements, but on how audits actually work in practice — on both sides of the table.
Structured GMP Approaches
Depending on scope and complexity, structured approaches — including controlled pilot projects or focused evaluations — may be applied.
These approaches are discussed individually and aligned with regulatory relevance.
Professional Exchange
If you are looking for independent GMP support, audit experience, or an objective assessment of your current compliance status, an initial professional exchange is possible.
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