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:
- Services include: Audit preparation & strategy development: We develop customized audit strategies and prepare you optimally for upcoming inspections.
- Conducting mock audits: Our experts conduct internal audits to identify potential risks and recommend corrective actions.
- Implementation of CAPA measures: We support you in the implementation of Corrective and Preventive Actions (CAPA) to ensure long-term compliance.
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 (Good Manufacturing Practice).
- Conducting GMP audits to ensure compliance with manufacturing standards
- Checking your production processes for conformity with regulatory requirements
- Support in preparing for regulatory inspections, e.g. FDA or EMA
GDP audits (Good Distribution Practice).
- Ensuring compliance in the areas of storage and distribution
- Support in optimizing your supply chain to comply with GDP regulations
- Conducting audits to ensure product safety throughout the entire supply chain
GLP audits (Good Laboratory Practice).
- Checking your laboratory processes and studies for compliance with GLP guidelines
- Support with the implementation of GLP standards in your company
- Preparation for laboratory inspections and audit follow-up
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.
Ensuring GMP compliance in a pharmaceutical production plant
Ensuring GDP compliance in a global biotechnology company
Optimization of GLP compliance in a research-oriented pharmaceutical company
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 documentation systems so that they always comply with current regulatory requirements.
Systematic calibration and maintenance of your equipment is crucial to avoid errors and ensure product quality. Our audit services help you identify gaps in maintenance schedules and implement appropriate calibration and maintenance measures.
The regular training of your employees and the complete documentation of this training are of central importance for compliance with the GxP standards. We offer training programs to ensure that your team is always familiar with the latest requirements and can put them into practice.
Our GxP audit consultancy places great emphasis on the implementation of a robust risk management system. This enables you to identify potential risks in your processes at an early stage and implement corrective measures. Continuous improvement of your processes ensures that you are always audit-ready and meet regulatory requirements in the long term.
We ensure that your manufacturing processes meet the strict requirements of Good Manufacturing Practice (GMP). Our experienced consultants support you in implementing a robust quality management system and assist you in preparing for audits and inspections by health authorities.
We offer comprehensive advice on optimizing your storage and distribution processes in accordance with the requirements of Good Distribution Practice (GDP). This ensures product safety along the entire supply chain and minimizes the risk of compliance violations.
Our Good Laboratory Practice (GLP) compliance 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:
