Pharmaceutical Quality
QA/QC Pharma Tools
Free QA/QC tools for pharmaceutical professionals. RPN calculator for FMEA, ISO cleanroom classification, GMP audit checklists, CAPA templates, stability schedule generator, and deviation reports.
These QA/QC tools are designed for pharmaceutical quality professionals — quality assurance managers, QC analysts, regulatory affairs specialists, and manufacturing supervisors. All tools follow ICH, FDA, EMA, and ISO standards.
Available Tools
FMEA Risk Priority Number: Severity × Occurrence × Detection
Open Calculator →ISO 1–9 cleanroom class from particle count data
Open Tool →Downloadable WHO/FDA/EU GMP audit checklists
Open Tool →ICH Q1A stability study timepoints: 0, 3, 6, 9, 12 months
Open Tool →Corrective and preventive action template for GMP deviations
Open Template →Structured deviation report template
Open Template →Out of Specification investigation workflow
Open Template →Self-assessment checklist for FDA/EMA inspections
Open Checklist →Cp, Cpk, Pp, and Ppk for validated process data
Open Calculator →MACO/PDE swab and surface limit planning
Open Calculator →About These QA/QC Tools
Pharmaceutical quality assurance and quality control require rigorous, documented processes. These tools help QA professionals apply recognized methodologies including ICH Q9 quality risk management, ISO 14644 cleanroom standards, and WHO/FDA/EU GMP requirements — directly in the browser, with no software installation or account required.
The RPN Calculator implements the FMEA methodology described in ICH Q9, enabling risk prioritization across failure modes using Severity, Occurrence, and Detection scores. The Cleanroom Classification Tool covers ISO 14644-1 Classes 1–9, EU GMP Grades A–D, and the legacy US Federal Standard 209E equivalents used in pharmaceutical manufacturing.
Who These Tools Are For
Quality Assurance Managers, QC Analysts, Regulatory Affairs Specialists, Manufacturing Supervisors, Validation Engineers, and Pharmaceutical Scientists who need fast reference calculations and templates aligned with current GMP expectations.
QA/QC & manufacturing suppliers
Find CDMO, CRO, and GMP-aligned vendor partners in the Pharma Supplier Hub.