White Paper: FDA’s Guidelines for GMP Of API
Published May 2021
Abstract:
Good Manufacturing Practices (GMP) ensure APIs and products are consistently produced and controlled according to quality standards. The quality of the API in a drug has a direct effect on the safety and efficacy of that drug. Therefore, GMP is a critical part of API development.
This white paper covers:
- API & GMP
- Quality by Design
- eCFR on GMP for APIs
- GMP Regulations and Guidelines
Keywords: API, dosage, cGMP, quality, quality by design, FDA, risk analysis, risk control, eCFR, API manufacturing, compliance, CAPA, audits, equipment maintenance, recalls, clinical trials, validation
Click here to view White paper: FDA’s Guidelines for GMP Of API