Which Guideline refer for Equipment Qualification

Question

Accepted Answer

The guidelines for equipment qualification vary depending on the industry and regulatory requirements.

In the pharmaceutical industry, equipment qualification is guided by regulations such as Good Manufacturing Practices (GMP) and the International Conference on Harmonisation (ICH) guidelines.
For medical devices, the guidelines may include the FDA's Quality System Regulation (QSR) and the ISO 13485 standard.
In the food industry, equipment qualification may be guided by regulations such as the Food Safety Modernization Act (FSMA) and the Hazard Analysis and Critical Control Points (HACCP) system.
Other industries may have their own specific guidelines or standards for equipment qualification, such as the American Society of Mechanical Engineers (ASME) codes for equipment used in the oil and gas industry.

Accepted Answer

FDA, MHRA, WHO required that GMP.

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