List of guidelines used in equipment qualification in pharmaceutical industry

Quality Assurance
1

Guidelines for equipment

2

EudraLex - Volume 4- Good Manufacturing Practice (GMP) Guidelines,

Annex 15- Qualification and Validation.

WHO - Supplementary Guidelines on Good Manufacturing Practices (GMP), part 2: Validation.

21 CFR 211 : current good manufacturing practice for finished pharmaceuticals.

ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition.

ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.

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