Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?
By Deb Bartel,
This post was recently updated on September 19, 2018
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
Download the FDA Guidance here: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
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.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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