Pharmaceutical Calculation Suite
Formulas, variable definitions, regulatory references, and step-by-step methods for every PharmaCalc calculator — cleaning validation, QC & analytical, and process control.
TL;DR: PharmaCalc is a web-based suite of 23 pharmaceutical calculators for cleaning validation (MACO, HBEL/PDE, swab & rinse limits), QC & analytical statistics (USP / ICH acceptance tests), and process control (SPC charts, capability, Gauge R&R). Every calculation follows published regulatory formulas and produces a GMP-style PDF report. The guides below document each calculator's formulas, variables, and references.
Maximum Allowable Carryover (MACO) for cleaning validation. Formulas, variables, and step-by-step method for the Therapeutic Dose, 10 ppm, HBEL/ADE, and LD50/NOEL approaches with GMP PDF reports.
Open calculator →Health-Based Exposure Limit / Permitted Daily Exposure per EMA/CHMP/SWP/169430/2012. Derives PDE from NOAEL or LOAEL toxicology data with F1–F5 adjustment factors — formulas, variables, and worked method.
Open calculator →Swab recovery study statistics: mean recovery, sample SD, %RSD, and 95% CI via t-distribution, evaluated against ISPE / FDA acceptance criteria (Mean ≥ 70%, %RSD ≤ 20%).
Open calculator →Rinse limit (mg/L) derived from MACO and total rinse volume, with analytical method LOQ suitability check. Full formula, variable definitions, and step-by-step tutorial.
Open calculator →Assesses whether visual inspection alone is adequate cleaning verification by comparing Surface Residue Limit (SRL) against Visual Detection Threshold (VDT), with adequate / marginal / inadequate verdicts.
Open calculator →USP <643> process-based TOC acceptance limit derived from MACO and % carbon, for rinse water or swab sampling. Governing limit is the more stringent of process-based and 500 ppb.
Open calculator →Acceptance Value (AV) per USP <905> Uniformity of Dosage Units. Two-stage acceptance: Stage 1 (n=10, AV≤15), Stage 2 (n=30, AV≤25) with individual-unit range check — formulas and worked steps.
Open calculator →Single-point immediate-release dissolution acceptance test per USP <711>. Sequential S1/S2/S3 stages with Q-based criteria and individual-unit checks — full acceptance rules explained.
Open calculator →Multi-point modified-release dissolution acceptance per USP <711> Table 3. User-defined time points with NLT / NMT / Range criteria and sequential L1/L2/L3 stages.
Open calculator →Stratified-sample blend uniformity per FDA guidance / ISPE PQLI: mean within range, %RSD ≤ max, and every location within individual limits across 8–30 locations.
Open calculator →Dissolution profile similarity per Moore & Flanner (1996), FDA 1997 and EMA 2010: f1 (difference) ≤ 15 AND f2 (similarity) ≥ 50, with the ≤1-point-above-85% and ≥3-time-point rules.
Open calculator →Assay workflow with single- or multi-point calibration, second-standard recovery, bracketing standards, LOQ verification, and sample %LC per USP <1225> / ICH Q2(R2).
Open calculator →Multi-lot linear regression with 95% one-sided confidence limits per ICH Q1E §4.1. Lower (potency) or upper (degradant) limits, extrapolation caps, and slope/intercept poolability analysis.
Open calculator →Analytical method validation statistics per ICH Q2(R2) / USP <1225>: accuracy (% recovery by level), precision (repeatability + intermediate with F-test), linearity, and regression-based LOD/LOQ.
Open calculator →Limit of Detection & Quantitation by three methods simultaneously: Signal-to-Noise (3:1 / 10:1), Calibration Curve (3.3σ/b, 10σ/b), and Blank Response (x̄+3σ / x̄+10σ).
Open calculator →Process capability indices per AIAG SPC / ISO 22514: Cp, Cpk (short-term via MR̄/d₂) and Pp, Ppk (long-term), σ-level, DPMO, histogram, and verdict against 1.00 / 1.33 / 1.67 thresholds.
Open calculator →Individuals & Moving Range control chart per AIAG SPC practice: σ̂ = MR̄/d₂ (d₂ = 1.128), Western Electric rules 1–5 for signal detection, estimated or specified limits.
Open calculator →Shewhart X̄ and R or S control charts from subgrouped data with AIAG SPC constants (n = 2..25) and Western Electric rules 1–5. Estimated or specified control limits.
Open calculator →Exponentially Weighted Moving Average chart per Roberts (1959) and the NIST/SEMATECH e-Handbook for detecting small sustained shifts (0.5σ–2σ). Time-varying and steady-state limits with tunable λ and L.
Open calculator →Normal tolerance intervals per ISO 16269-6:2014: two-sided or one-sided bounds with specified coverage and confidence using the standard's exact k-factor, plus in-spec assessment.
Open calculator →Measurement system analysis via two-way crossed ANOVA per AIAG MSA 4th Ed. Decomposes variation into Equipment, Operator, Interaction, and Part; reports %GRR and ndc with verdicts.
Open calculator →Detect statistical outliers in analytical data using Grubbs (ISO 5725-2), Dixon Q (ASTM E178), and Generalized ESD (Rosner 1983), with consensus verdict and USP <1010> assignable-cause guidance.
Open calculator →Acceptance sampling plans by attributes per ANSI/ASQ Z1.4 / ISO 2859-1: code-letter lookup with arrow rules, OC curve, LTPD, AOQL, and Accept/Reject verdicts.
Open calculator →PharmaCalc (pharmacalc.net) is a web-based suite of 23 pharmaceutical calculators covering cleaning validation (MACO, HBEL/PDE, swab and rinse limits), quality control and analytical statistics (USP and ICH acceptance tests), and process control (SPC control charts, process capability, Gauge R&R). Every calculator follows published regulatory formulas and generates a GMP-style PDF report.
Cleaning validation: MACO — Maximum Allowable Carryover; HBEL / PDE — Health-Based Exposure Limit; Swab Recovery Statistics; Rinse Sampling Limit; Visual Inspection Adequacy; TOC Acceptance Limit. Quality control & analytical: Content Uniformity (USP <905>); Dissolution IR (USP <711>); Dissolution MR (USP <711>); Blend Uniformity; Dissolution f1 / f2 Similarity; General Assay (HPLC / UV); Stability & Shelf Life (ICH Q1E); Method Validation (ICH Q2(R2)); LOD / LOQ (ICH Q2(R2)). Process control & statistics: Cpk / Ppk Process Capability; I-MR Control Chart; X̄-R / X̄-S Control Chart; EWMA Control Chart; Statistical Tolerance Intervals; Gauge R&R (AIAG MSA); Outlier Testing (Grubbs · Dixon Q · ESD); AQL Sampling (ANSI/ASQ Z1.4).
Calculations implement published methods from USP general chapters (<905>, <711>, <643>, <1010>, <1225>), ICH guidelines (Q1E, Q2(R2)), the EMA HBEL guideline (EMA/CHMP/SWP/169430/2012), ANSI/ASQ Z1.4 / ISO 2859-1, AIAG SPC and MSA manuals, and ISO 16269-6:2014. Each guide page documents the exact formulas, variables, and references used.
PharmaCalc has an open demo: every calculator can be explored end-to-end with sample data, including its PDF report, with no account required. A paid subscription unlocks calculations with your own data. Current pricing is listed at pharmacalc.net/plans.
Yes. Every calculation generates a GMP-style PDF report listing the inputs, formulas applied, intermediate values, results, and pass/fail verdicts against the relevant acceptance criteria, suitable for attachment to validation protocols and QC records.
PharmaCalc is built for pharmaceutical QA/QC analysts, cleaning validation engineers, analytical method developers, and process/quality engineers who need standards-based calculations without building and validating their own spreadsheets.