In September, the FDA published Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients to provide API manufacturers with recommendations intended to ensure compliance with regulations.
What is in the new FDA Guidance:
This guidance document, originally published by ICH in 2000, includes recommended best practices for computer systems, such as:
- Validation
- System documentation
- Security
- Record protection and retention
- Audit trails
- SOPs for system use and support
- Change management
- Incident investigation
Do you need more help implementing these recommendations in your organization? Talk to our CSV experts about how you can update your practices for compliance.