Expertise.
Annex 1 Consulting.
Ensure that your processes comply with the new Annex 1 requirements for sterile products and are GMP-compliant.
Compliant?
Do you meet all regulatory requirements of the current Annex 1 guidelines for sterile products?
Efficient?
Optimize your manufacturing processes for sterile medicinal products in accordance with current GMP requirements.
Secure?
Minimize risks and ensure continuous compliance with GMP requirements.
Ensure your GMP compliance according to Annex 1.
Annex 1 Compliance advice.
Our Annex 1 consulting supports you in complying with the new GMP guidelines for sterile drug production and helps you to adapt and optimize your processes.
GMP audits are a crucial step in ensuring compliance with the current Annex 1 requirements. Our experts will guide you through the entire audit process - from the preparation phase to the successful inspection by the authorities. Through tailor-made solutions, we support you in optimizing your processes, creating documentation and implementing a robust quality system for sterile products.
Our services include:
- Audit preparation & strategy development: We create individual strategies for preparing for Annex 1 GMP inspections.
- Conducting internal audits: Our experts carry out audits to evaluate your processes and identify necessary improvements.
- Follow-up & continuous improvement: We support you in the implementation of corrective measures and the continuous optimization of your quality system for sterile products.
Our expertise in Annex 1 compliance.
Our Annex 1 consulting covers all requirements of the current GMP regulations and offers you tailor-made solutions to optimize your sterile production and ensure GMP compliance.
Gap analysis and risk management.
- Carrying out comprehensive gap analyses to ensure compliance with the new Annex 1 requirements
- Development of a risk management approach to identify critical vulnerabilities
- Implementation of measures to minimize risks
Aseptic Process Validation.
- Validation and optimization of aseptic processes in accordance with Annex 1 guidelines
- Development and implementation of process optimizations to improve sterile production
- Support for continuous monitoring and validation
Environmental monitoring
monitoring.
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Development and optimization of monitoring
processes for cleanrooms and sterile production environments - Ensuring compliance with all environmental guidelines and regulatory requirements
- Training employees to implement Annex 1 requirements
Successful Annex 1 projects.
Our successful Annex 1 compliance projects show how we have helped companies meet the stringent requirements of sterile drug production.
Annex 1 compliance in a global pharmaceutical company
Compliance for Annex 1 in a medium-sized biotech company
Challenge.
A medium-sized biotech company had to adapt its production processes to the stricter requirements of Annex 1 in order to remain GMP-compliant.
Measures.
- Optimization of aseptic processes and validation of existing production methods
- Development of an improved risk management approach for sterile production
- Training the entire production team on the new requirements
Results.
- Successful implementation of the new processes in 4 months
- Reduction of production losses by 30 % through optimized processes
Success.
The company passed the subsequent GMP inspection and was able to continue production without any further interruptions.
Meet the requirements of Annex 1.
Our Annex 1 service portfolio.
Our Annex 1 consultancy offers you customized solutions for the preparation, implementation and follow-up of audits to ensure GMP compliance in sterile pharmaceutical production.
Cleanroom monitoring is one of the key components of the new Annex 1 directives. We support you in developing a risk-based environmental monitoring strategy to ensure compliance with the requirements. In doing so, we ensure that your monitoring processes comprehensively cover living and non-living particles and that all relevant data is analyzed in real time.
The integration of new technologies such as Single-Use Systems (SUS), Restrict Access Barrier Systems (RABS) and isolators is a key requirement of the new guidelines. We help you to seamlessly integrate these technologies into your production processes to minimize the risk of contamination and maximize the efficiency of your sterile production processes.
An important part of the new Annex 1 requirements is strict compliance and validation of aseptic processes. We support you in implementing strict sterilization techniques and performing filter integrity testing (PUPSIT) to ensure that your processes meet all regulatory requirements.
The new guidelines place great emphasis on the training of personnel in class A and B cleanrooms. Our services include comprehensive training programs to ensure that your team understands the necessary requirements for sterile production and is regularly kept up to date. This includes training on the correct use and disinfection of cleanroom garments.
Ensure your GMP compliance for sterile medicinal products.
Annex 1 - Related topics for the implementation of cleanroom and hygiene standards.
These supplementary services support you in complying with the latest requirements for aseptic processes:
