How pharma firms benefit from new FDA cGMP process validation guidelines

The new guidelines on process validation in current Goods Manufacturing Processes (cGMP) issued by the US Food and Drug Administration have come a long way from the original stipulations made way back in 1987. Michael Goodman, compliance specialist at USA-based consultancy Compliance Insight, points out that the new guidelines - more suited to the 21st Century - emphasize three key points:

• Implementation of modern pharmaceutical development concepts
• Quality risk management
• Quality systems at all stages of the manufacturing process life cycleThe most evident and immediate benefits for pharmaceutical companies are:
• Variations would be checked before contaminants enter the product supply chain
• Better monitoring of critical quality attributes of a product in process
• Greater checks on process drift or unnoticed supply chain changes
• Minimal risk of growing dependence on contract manufacturing companies, or CMOs, that manufacture different drugs with different risks for different companies

Mr Goodman explains that the new FDA guidelines have fragmented process validation with the modern 'Quality by Design' approach. Each step is now characterized in the entire process. Manufacturers would now have to define each step as non-critical or critical according to the following evaluation: