Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?

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.

Pharmaceuticals, Guidance & Regulations

Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?

What is in the new FDA Guidance:

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