Zdrowie i gospodarka · 15/04/2016

FDA Releases Draft Guidance on Data Integrity and Compliance With CGMP Regulations

The Food and Drug Administration (FDA) has released a draft guidance for the pharmaceutical industry on data integrity and compliance with Current Good Manufacturing Practice (CGMP) regulations, following an increase in CGMP violations related to data integrity in recent inspections. The guidance aims to clarify the role of data integrity in CGMP for drugs and provide the FDA's current thinking on data creation and handling.