GMP Advice

GMP Advice is an independent service company that specializes in consulting and implementing GMP and EHS requirements in the life sciences industry. GMP Advice supports pharmaceutical and biotech companies in all questions regarding compliance with legal standards and regulations, in particular good manufacturing practices (GMP), but also environment, health and occupational safety (EHS) GMP Advice understands complex situations and tasks, develops well-founded and pragmatic solutions, supports customers in implementation and gets involved … with expertise, empathy and enthusiasm. „30 years of professional experience in the pharmaceutical industry, including 20+ years in management.“ Special focuses 📌 Interim management 📌 Authority management (incl. inspections – FDA, EDQM, PMDA, kFDA, local surveillance authority) 📌 External audits (ca. 100 performed) 📌 Supplier management 📌 Validation, qualification 📌 Cleaning validation 📌 Raw material testing 📌 Employee qualification, training, elearning 📌 CMO management, quality agreements 📌 Deviations 📌 Change control 📌 CAPAs 📌 Quality risk management 📌 Management reviews, PQR 📌 Internal audits 📌 Environment, health and occupational safety