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 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.
All about Quality Assurance
- Manufacturing authorisation according to the German Medicinal Products Act AMG §13
- EU GMP certified acc. 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
- Continous 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
Our Experts For you
Our Experts - Your Partners
Overview of key contacts - supported by many more specialists working for our partners and Clients behind the scenes.
Dr. Frank Velte
Head of CG Pharma & Biotech
+49 (0)511 87803-106
+49 (0)152 3466 7631
frank.velte@cg-chemikalien.de
Marco Regel
Head of Sales & Business Development
+49 (0)511 / 87803-146
+49(0)511 / 2516696
marco.regel@cg-chemikalien.de
Thomas Metzger
Sales & Business Development Manager
+49 (0)511 87803-258
+49 (0)79 483 72 81
thomas.metzger@cg-chemikalien.de
Verena Diederich
Head of Quality Management
+49 (0)511 87803-870
+49 (0)173 / 3857408
verena.diederich@cg-chemikalien.de
