GMP Compliance/Audit
Adherence to Good Manufacturing Practice (GMP) is essential for pharmaceutical production. Audits and compliance checks ensure that your processes, facilities, and documentation meet regulatory requirements. We support you in working in a GMP-compliant manner and ensuring audit readiness.
COMPLIANCE, QUALITY & AUDIT READINESS
Work GMP-compliant – securely, documented, audit-ready
GMP requirements do not only concern audits, but the entire production and quality process. They demand clear structures, robust documentation, and traceable decisions.
Our Services at a Glance
GAP
Analysis
We identify weaknesses in your processes and provide recommendations for improving GMP compliance.
Documentation Review
SOPs, batch documentation, and validation documents are checked for completeness and GMP compliance.
Production Site Inspection
We verify that your production sites comply with regulatory requirements.
Audit Preparation & Support
Preparation for internal and external audits is optimized through pre-audits and mock inspections. We support you during their execution.
Emergency Management for Quality Deviations
We develop and implement measures for the rapid elimination of deviations.
Internal Audits & Supplier Audits
Own processes and suppliers are specifically audited to ensure quality and GMP compliance.
Your Benefits with DPhE
Experience
30 years
of GMP experience
Practical Orientation
Strategic consulting
with practical relevance
Support
Flexible support for urgent issues
Teamwork
Interdisciplinary
Teams