Manufacturers are obliged to qualify their suppliers on a regular basis by performing GMP and GDP Audits. In addition, sponsors of clinical trials have to ensure that suppliers of external services are qualified.
3R PHARMA CONSULTING provides audits of suppliers in every part of the world based on long-term experience and expertise.
What we offer:
- Qualification of suppliers based on Risk Assessments;
- Conducting external GMP audits of manufacturers and suppliers of APIs and finished dosage forms;
- Audits of warehouses (GDP);
- Audits of external service providers like QC labs;
- Preparation of manufacturers for regulatory inspections ("Mock inspections");
- Support of Self-inspections.