Expertise.
GMP consulting.
Efficient?
Compliant?
Do you meet all GMP specifications and regulatory requirements?
Sustainable?
Do you meet all GMP requirements and ensure efficient production processes?
GMP consulting - efficient processes and full compliance.
Our services include:
- GMP process analysis: We analyze your existing production processes and identify potential for improvement to ensure compliance with GMP guidelines.
- Regulatory support: We offer advice on compliance with national and international GMP regulations and guide you through the entire audit process.
- Training and education: We offer customized GMP training for your team to ensure that all employees are familiar with the latest GMP requirements.
- Audit preparation: Our team prepares you optimally for GMP audits and supports you in preparing the necessary documentation.
Our GMP services at a glance.
GMP process analysis.
- Analysis of existing processes to identify potential for improvement
- Development of measures to optimize production processes
- Introduction of digital monitoring systems for real-time compliance
Regulatory support.
- Advice on national and international GMP regulations
- Support with audit preparation and submission of documents
- Implementation of measures to ensure regulatory compliance
Training and qualifications.
- Customized GMP training for all employees
- Introduction of training programs for continuous professional development
- Qualification of personnel to ensure GMP compliance
Successful GMP projects.
Challenge.
A pharmaceutical company was struggling to ensure data integrity and traceability in its production processes, jeopardizing GMP compliance.
Measures.
- Introduction of an electronic quality management system (eQMS) to automate data collection
- Implementation of real-time dashboards for monitoring production processes
- Staff training to ensure GMP-compliant documentation
Results.
- 35% Improvement in data integrity
- 40% increase in the traceability of production processes
- Successful GMP audits without complaints
Success.
The company was able to significantly improve GMP compliance and strengthen the traceability of its production processes.
Challenge.
A pharmaceutical company needed support to make its production processes more efficient and at the same time comply with GMP requirements.
Measures.
- Implementation of comprehensive GMP training for the entire production team
- Introduction of best practices for compliance with GMP requirements
- Revision of existing production processes to increase efficiency
Results.
- 20 % increase in efficiency in production processes
- 100% compliance with GMP standards after the training courses
- Improved audit preparation and compliance
Success.
The company was able to make its production processes more efficient and ensure GMP compliance.
Challenge.
A medium-sized pharmaceutical company was faced with the challenge of implementing the new EU regulations and avoiding sanctions.
Measures.
- Carrying out a comprehensive compliance analysis to assess the new regulations
- Development of a compliance management system to comply with the new regulations
- Training the team on the new regulations and their impact
Results.
- Full implementation of the new EU regulations within six months
- Improvement of the company's documentation processes and audit capability
- Minimizing the risks of compliance violations and avoiding potential sanctions
Success.
The company was able to successfully implement the new regulations and secure its position on the European market.
Ensure your GMP compliance and optimize your operational processes.
Our Good Manufacturing Practice portfolio at a glance.
Our experts analyze your production processes, identify bottlenecks and implement measures to optimize efficiency and ensure compliance with GMP requirements. This includes reviewing documentation and adapting to international standards such as EU GMP EudraLex, ICHQ7 and 21 CFR Part 820.
Further information can be found in the EU GMP Guidelines (EudraLex Volume 4) and the ICH Guidelines (ICH Q7).
We offer comprehensive support in preparing for audits and inspections by international regulatory authorities such as the FDA, EMA, ANVISA and others. Our team accompanies you throughout the entire process and ensures that all regulatory requirements according to EU GMP EudraLex, ICH Guidelines and other standards are met.
Additional information on the regulatory requirements can be found on the official website of the EMA.
We provide customized GMP training for your team to ensure that all employees are familiar with the latest GMP and GDP requirements. In addition, we implement training systems and provide mentoring to ensure continuous compliance with standards.
Additional resources for training materials: