Equipment validation in pharmaceutical industry

General
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Equipment Validation in Pharmaceutical Industries

:white_check_mark: What is it?
A systematic, documented process that ensures pharmaceutical equipment performs reliably, safely, and compliantly throughout its lifecycle.

:scroll: Regulatory Framework

:diamond_suit:FDA (21 CFR 211.63): Design, risk-based validation, revalidation.
:diamond_suit:EMA (Annex 15): Lifecycle approach, risk management, exposure limits.
:diamond_suit:ICH (Q8–Q10): Science-driven, risk-based, global harmonization.

:gear: Stages of Validation

:one: Design Qualification (DQ): Confirms design meets user & regulatory needs.
:two: Installation Qualification (IQ): Proper installation & calibration checks.
:three: Operational Qualification (OQ): Testing under operating ranges & safety systems.
:four: Performance Qualification (PQ): Reliability under real production conditions.

:open_file_folder: Phases

:small_blue_diamond: Pre-Validation – Planning, URS, risk assessment.
:small_blue_diamond: Process Validation – Controlled testing & data analysis.
:small_blue_diamond: Validation Maintenance – Requalification, change control, monitoring.

Equipment validation
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Equipment validation
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MBH/PS

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Equipment inspection ensures pharmaceutical machines are safe and reliable. It ensures process consistency and regulatory compliance, from design verification to real-world production testing and maintenance.

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