Comprehensive guides covering FDA, EMA, and international regulatory standards for pharmaceutical equipment qualification and validation.
21 CFR Part 11, Part 210, Part 211
EU GMP Annex 15, ICH Guidelines
ISO 9001, ISO 14644, ISO 17025
GAMP 5, Baseline Guides
FDA COMPLIANCE IMAGE
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Comprehensive guide to FDA regulations for pharmaceutical equipment including 21 CFR Part 11 electronic records requirements.
EU GMP IMAGE
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European GMP guidelines for qualification and validation of pharmaceutical equipment and computerized systems.
VALIDATION GUIDE IMAGE
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Step-by-step validation protocols for pharmaceutical equipment including IQ/OQ/PQ documentation requirements.
AUDIT CHECKLIST IMAGE
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Comprehensive checklist for preparing for FDA, EMA, and other regulatory inspections of pharmaceutical facilities.
