Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement. Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on […]

Six Systems Approach to Pharmaceutical cGMP Regulations

Six Systems Approach to Pharmaceutical cGMP Regulations. The FDA has enacted several pharmaceutical cGMP regulations. These are key concepts that are critical to quality systems. Some of the concepts by which the FDA and other regulatory bodies ensure cGMP regulations are Quality, Quality by Design (QbD) and product development, Quality Risk Management, Corrective and Preventive […]