Expertise.

GxP Audit Consulting.

Effective support for audit preparation and compliance in pharma and biotech.

Compliant?

Do you meet all the regulatory requirements of GMP, GDP and GLP?

Efficient?

Optimize your production and quality processes for successful audits.

Secure?

Minimize risks and ensure compliance with all regulations.

Ensure your compliance and audit your processes.

GxP Audit Consulting.

Our GxP audit consultancy helps you to successfully implement the regulatory requirements of GMP, GDP and GLP in your processes.
GxP audits are critical for compliance with regulatory standards in the life sciences industry, including pharma and biotech. Our experts can help you prepare and conduct internal and external audits and implement corrective actions to address potential weaknesses. Our services include developing a robust audit program, conducting simulated audits (mock audits) and training your staff to ensure continuous compliance with GMP, GDP and GLP. We support you throughout the entire audit process, from audit preparation and execution to the follow-up of measures for ongoing compliance.

Our services include:

Discover our expertise in GxP audits.

Our comprehensive GxP audit consultancy offers you the support you need to ensure your compliance and minimize risks in your processes.

GMP audits.

GDP audits.

GLP audits.

Successful GxP audit projects.

Our case studies show how we have helped companies meet the strict requirements of GMP, GDP and GLP and ensure their compliance.

Challenge.

A research-oriented pharmaceutical company needed support in optimizing its laboratory processes in order to meet the strict requirements of GLP (Good Laboratory Practice) and successfully pass regulatory inspections.

Measures.

  • Carrying out a comprehensive GLP audit to check compliance with the guidelines in the laboratory processes
  • Development and implementation of an improvement plan to optimize documentation processes and sample management
  • Training of laboratory staff in GLP requirements and introduction of a monitoring system to ensure continuous compliance with standards

Results.

  • Successful implementation of new GLP-compliant processes and improvement of laboratory procedures
  • Passed regulatory inspection without objections

Success.

The pharmaceutical company was able to optimize its laboratory processes, fully comply with GLP requirements and increase productivity in the laboratory area.

Ensure your compliance - with GxP Audit Consulting.

Our GxP Audit Consulting portfolio.

Our GxP audit consultancy offers you comprehensive support in complying with the regulatory requirements of GMP, GDP and GLP in the pharmaceutical and biotechnology industry. 

A well-structured document management system is essential to ensure compliance with GxP regulations. We support you in regularly reviewing and updating your standard operating procedures (SOPs) and in implementing audit-proof documentation systems. Further information on the requirements can be found in the FDA guidelines and the EMA guidelines.

Systematic calibration and maintenance of your equipment is crucial to avoid errors and ensure product quality. We identify gaps in your maintenance schedules and support you in implementing robust calibration and maintenance processes. You can find out more about these standards in the ISO standards.

Die regelmäßige Schulung Ihrer Mitarbeiter ist von zentraler Bedeutung für die Einhaltung der GxP-Standards. Wir bieten praxisorientierte Schulungsprogramme, die sicherstellen, dass Ihr Team stets mit den aktuellen Anforderungen vertraut ist und diese effektiv umsetzt. Weitere Informationen finden Sie in den <a href=“https://ichgcp.net/“ target=“_blank“>ICH-GCP-Leitlinien</a>.

A robust risk management system enables you to identify potential risks at an early stage and eliminate them through preventive measures. Our services support you in the implementation and continuous optimization of your processes in order to meet regulatory requirements in the long term. Visit our Risk Management page for more details.

Our experienced consultants carry out GMP audits to ensure that your manufacturing processes meet the strict requirements of Good Manufacturing Practice. We support you in implementing a robust quality management system and preparing for audits and inspections.

We optimize your storage and distribution processes in accordance with the requirements of Good Distribution Practice. This ensures product safety along the entire supply chain and minimizes the risk of compliance violations.

Our GLP audits help you to optimize your laboratory processes and ensure that your studies comply with GLP regulations. We prepare you for laboratory inspections and support you in maintaining the highest quality standards.

With increasing globalization, compliance with GxP standards in different countries is a challenge. We support you in carrying out consistent audits worldwide and mastering regional differences in regulatory requirements. In this way, we ensure the quality of your international supply chains and production facilities.

Ensure your GxP compliance - with Entourage.

Related topics for compliance with GxP standards.

These supplementary services support you in the preparation and implementation of GxP-compliant audits to ensure the highest quality and safety standards:
CAPA Management
Optimize your processes with a robust CAPA system to ensure compliance and ...
Inspection Readiness
Ensure that your products and processes comply with regulatory requirements.
Risk Management
Identify and minimize risks with solutions for the pharmaceutical and medical technology industries.
ISO Audits
Ensure your compliance and optimize your processes in accordance with ISO 13485 and ...