Quality Assurance is in our DNA
Our comprehensive quality systems ensure that every product meets the highest standards of safety, reliability and regulatory compliance while respecting regulations by inspection bodies and the requirements of our business partners.
Through rigorous controls, validated processes and continuous improvement, we safeguard the integrity of our products and the trust of our customers.
Our dedicated team works proactively to identify and mitigate risks, ensuring consistent quality from raw material sourcing to final product release and transport. With a strong focus on transparency and accountability, we are committed to supporting our clients' success and upholding patient safety at every step.
- Manufacturing authorisation according to the German Medicinal Products Act (AMG) §13
- EU GMP certified according to Part 1 + 2
- IPEC-GMP for excipients certified by EXCiPACT standard
- Comprehensive quality systems and validated processes
- Quality assurance agreements with customers and suppliers
- Rigorous batch review and release by qualified personnel
- Risk-based management
- Change control
- CAPA/OOS system
- Continuous improvement
- Product quality review
- Batch record review
- ICH Q9-based risk management and robust supplier qualification
- Audit and training system
- Strict adherence to GMP and ISO 9001:2015 standards
- Process, cleaning and method validation
- Room and equipment qualification
- Software validation
- Over 60 standard operating procedures (SOPs) and work instructions
- Regular audits by leading pharmaceutical companies
- Commitment to continuous improvement and patient safety
- Continuous cleanroom monitoring and clean corridor concept
- In-house chemical-physical and microbiological laboratories
Quality Accreditations
Pharma & biotech | QUALITY & SUSTAINABILITY | ||
|---|---|---|---|
EU GMP certified according to part 1 + 2 | GDP | ISO 9001 | Responsible care |
Manufacturing authorisation according to the German Medicinal Products Act (AMG) §13 | IPEC-GMP for excipients certified by EXCiPACT standard | ISO 50001 | EcoVadis |
ISO 14001 | Kosher/halal |
