Pharma & GMP Quality Tools
USP compendial calculators, CAPA, OOS, stability, EM, and batch yield — free instant QA math.
Screening calculators for sterility sampling, endotoxin, particulate, reserve samples, hold time, and batch reconciliation. Pair with Pharma Quality Studio for audit-ready memos.
USP <71> Sterility Sampling Calculator
USP <71> sterility sampling — Table 3 articles by batch and product type, Table 2 minimum mL per medium, total test volume, and ×2 rule when fill is too small for two media.
Use toolarrow_forward
USP <788> Particulate Sampling Calculator
Calculate USP <788> particulate test sample size from batch article count — tier table aligned with injectable particulate examination planning.
Use toolarrow_forward
USP <85> Endotoxin Limit Calculator
Estimate bacterial endotoxin limits for parenterals using USP <85> K/M screening — parenteral vs intrathecal routes for LAL batch release planning.
Use toolarrow_forward
Reserve Sample Calculator (21 CFR 211.170)
Calculate minimum reserve sample quantity under 21 CFR 211.170 — twice the units consumed by release testing, with optional USP <71> sterility auto-fill.
Use toolarrow_forward
Stability Pull Schedule Planner
Generate stability study pull-point calendar from T0 — typical ICH long-term, accelerated, and intermediate time points for QC planning.
Use toolarrow_forward
OOS Retest Calculator
Screen assay or content-uniformity results against L1/L2 limits — see if retest units are indicated before full OOS investigation.
Use toolarrow_forward
Hold Time Tracker
Track manufacturing hold time from last clean — hours remaining or excursion for batch campaign and equipment use planning.
Use toolarrow_forward
Cleanroom EM Excursion Calculator
Compare cleanroom particle counts to EU GMP Grade A–D action and alert limits — normalized per m³ for EM excursion screening.
Use toolarrow_forward
CAPA Due-Date Tracker
Plan CAPA timelines from a non-conformance date — investigation, corrective action, and effectiveness check due dates.
Use toolarrow_forward
Batch Yield Calculator
Calculate batch yield percentage and loss for pharma manufacturing reconciliation.
Use toolarrow_forward
Pharma Unit Converter
Pharmaceutical mass and concentration conversions for QA and formulation homework.
Use toolarrow_forwardWant personalized help?
These tools run instantly in your browser — no AI credits. Sign in free to chat with a specialist agent and build audit-ready documents, lesson plans, or financial scenarios in Studio.
Create free accountarrow_forward