The Active Pharmaceutical Ingredient Committee (APIC) Publishes a Draft “How to do” Document on GDP

The Active Pharmaceutical Ingredient Committee (APIC) of the European Chemical Industry Council (CEFIC), the trade association representing European chemical manufacturers, recently issued a draft “How to do” document to provide guidance on good distribution practices (GDPs) for active pharmaceutical ingredients (APIs). 

The document is available here: http://apic.cefic.org/pub/GDPHowtoDo_201405.pdf and it interprets the WHO Guideline: “Good Trade and Distribution Practices for Pharmaceutical Starting Materials” and the Guidelines on the Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use issued by the European Commission (DG Sanco).  The document was prepared by industry experts from APIC/CEFIC and intends to “provide examples of commonly applied solutions and practical assistance on how requirements and recommendations can be met and/or interpreted.”