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WHO GMPs for Pharmaceutical products. Medicinal products and Investigational Medicinal products. ISO 9001- Quality Management System. Requirements.The quality manual should cover relevant EN ISO 9001 and GMP requirements, describe the documentation hierarchy and indicate how the quality system is managed. What is Quality Manual? It is simply a document that describes the quality management principles of a pharmaceutical organization. The document explains the It is fully aligned with the ICH Q10 Pharmaceutical Quality. System. The Sanofi QMS is intended to ensure that Sanofi products and services satisfy the We are pleased to share with you the first Guerbet Group Quality Manual! Guerbet is a Global Pharmaceutical and Medical Device group founded in France