White Papers related to GxP Audit
White Paper
Legal and regulatory requirements, including GMP and GDP guidelines, require consistently that medicinal products shall be stored and transported in a way that the product delivered maintain their quality and integrity and remain within the legal supply chain during storage and/or transportation. Storage and transport need to be described in the Pharmaceutical Quality System and the principles of quality risk management shall be used for designing and managing these activities.
White Paper
Download our recent whitepaper to gain deep insights into the Monitoring Compliance with Safety Exchange Agreements.
White Paper
Download our recent whitepaper to gain deep insights into the mutual recognition of inspections of medicinal product manufacturers between the EU and the USA.