Pharma Calculators — Phase 1
⭐ Most Used
Process Capability / Cpk Calculator
Calculate Cp, Cpk, Ppk and Six Sigma level from your process data. Paste values or enter mean & SD. Visual gauge chart with ICH Q8 benchmarks. Instant pass/fail verdict.
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Cpk Result
1.54
CAPABLE ✓
Cp
1.67
Sigma
4.6σ
FDA/EMA Guided
Dissolution f2 Similarity Calculator
Compare dissolution profiles using the f2 similarity factor. Enter time-point data for reference and test products. Instant PASS/FAIL vs the ≥50 threshold with full regulatory context.
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ICH Q9
FMEA / RPN Risk Matrix
Build a full Failure Mode & Effects Analysis table. Score Severity, Occurrence and Detection (1–10) and auto-calculate the Risk Priority Number. Visual risk heatmap and CSV export included.
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ICH E9
Sample Size Calculator
Calculate the required sample size for clinical trials and comparative studies. Supports two-proportion and two-mean comparisons with α, power, and effect size inputs. Sensitivity analysis included.
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ICH Q1E
Stability Shelf Life Estimator
Use Arrhenius kinetics to estimate shelf life at ICH long-term conditions (25°C). Enter degradation rate constants at elevated temperatures. Visual Arrhenius plot with extrapolation to real-world storage.
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🏆 Featured Tool
Pharma PDF Toolkit & GMP Stamp
Edit, merge, split and GMP-stamp pharmaceutical PDF documents. Apply APPROVED / REJECTED / UNDER REVIEW stamps with audit trails. The most-used pharma PDF tool in Ireland.
Open PDF Toolkit ↗
Pharma Quality & Pharmacokinetics — Phase 2
ICH Q10
SPC Control Chart Generator
Monitor process stability using an Individuals (I-Chart) control chart. Input raw values to auto-calculate limits (UCL/LCL) and check Nelson/Westgard rules violations.
Open Generator
Pharmacokinetics
NCA / PK Calculator
Perform non-compartmental pharmacokinetic analysis. Enter time-concentration data to calculate Cmax, Tmax, AUC0-t, AUC0-inf, clearance, Vd, and half-life.
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FDA/EMA Guided
Bioequivalence 90% CI
Calculate GMR and 90% Confidence Intervals for parallel or crossover designs. Uses Two One-Sided Tests (TOST) against the standard 80.00%–125.00% acceptance limits.
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FDA Aligned
OOS Investigation Workflow
Document laboratory Out-of-Specification failures using systematic Phase Ia/Ib and Phase II checklists. Includes Grubbs' outlier test and print-ready report format.
Open Workflow
ICH Q9
GMP Risk Register
Create Quality Risk Registers with initial and residual Risk Priority Number (RPN) matrix scoring. Optimized for landscape A4 PDF printing and CSV export.
Open Register
Pharma Compliance & GMP Workflows — Phase 5
21 CFR 211.160
Calibration Due Tracker
Track instrument calibration due dates and intervals. Monitor status with active, due soon, and overdue alerts. Export calendars as CSV and PDF layouts.
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Annex 1 Aligned
EM Cleanroom Limits
Verify particulate and viable CFU microbial levels against EU GMP Annex 1 (2022) and ISO 14644-1 limits. Instantly flags out-of-specification contamination.
Open Limits
Batch Release
COA Generator
Draft and compile batch Certificate of Analysis sheets. Formulate parameter specification grids, check conformance status, and download A4 compliance printouts.
Open Generator
Cold Chain
GDP Temp Excursion Report
Log shipment temperature readings and calculate Mean Kinetic Temperature (MKT) per USP <1159> to assess GDP deviations.
Open Analyzer