Can I read FDA Equipment Qualification Guidelines on EtoBox?
FDA Equipment Qualification Guidelines by Dharmesh Patel is a document available to read on EtoBox.
What is FDA Equipment Qualification Guidelines about?
The document discusses equipment qualification requirements from a regulatory perspective. It summarizes common issues found in FDA warning letters related to equipment calibration and qualification. These include inadequate calibration programs, procedures that do not meet recognized standards, and lack of acceptance criteria. The summary emphasizes that equipment must be properly tested and qualified to demonstrate it can perform as intended and meet pre-determined requirements.
- Author
- Dharmesh Patel
- Language
- EN