Increased importance of the documented development stage in process validation

Area of Science:

• Pharmaceutical quality assurance
• Process validation

Background:

• The US FDA's 2011 guideline introduced a lifecycle approach to process validation.
• This shift impacts pharmaceutical quality assurance and API production practices.

Purpose of the Study:

• To address typical changes in API production due to the new FDA process validation guideline.
• To compare these changes with European regulations.

Main Methods:

• Analysis of practical changes in API production.
• Comparison with European regulatory standards.
• Review of inspection experiences.

Main Results:

• The FDA's lifecycle approach necessitates significant adjustments in API production.
• Inspection experiences highlight practical challenges and adaptations.
• Differences and similarities exist between US and European regulatory approaches.

Conclusions:

• The FDA's 2011 process validation guideline has driven substantial changes in pharmaceutical API production.
• Understanding these changes and comparing them with European regulations is crucial for global compliance.