Content_Uniformity_Acceptance_Value

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of Content_Uniformity_Acceptance_Value. The utility is intended for automated verification of laboratory, pharmacopoeial, analytical or manufacturing QC parameters using input.csv and producing a structured output.json result.

Domain limits and critical parameters

• • This is a critical quality attribute for solid dosage forms with low API potency.
• • USP <905> and Ph. Eur. 2.9.40 use a statistical approach (Acceptance Value) to assess variability.
• • AV calculation accounts for both bias (accuracy) and spread (precision).
• • Automation eliminates manual calculation errors for standard deviation and AV.
• • For Stage 1 (n=10), the AV limit is 15.0.
• • If AV > 15.0 but ≤ 25.0, testing of additional 20 units may be required (Stage 2).
• • Any unit outside 75.0–125.0% of Label Claim leads to batch failure at Stage 1.
• • M value adjusts if mean deviates from 98.5–101.5%, penalizing for bias.
• • Automatic AV calculation per USP/Ph.Eur. formula.
• • Check of individual limits (75-125%).
• • Generation of LIMS-compatible JSON report.
• • Acceptance Value (AV): <= 15.0
• • Individual Limits: 75.0% - 125.0%
• - M: reference value (100.0 if 98.5 ≤ x̄ ≤ 101.5; otherwise boundary)
• • Passing Criteria (Stage 1): AV ≤ 15.0 AND all units within 75.0–125.0%.

URS — User Requirements Specification

input.csv contract

BatchNumber,Unit1%,Unit2%,Unit3%,Unit4%,Unit5%,Unit6%,Unit7%,Unit8%,Unit9%,Unit10%
TAB-CU-2026-001,98.5,101.2,99.0,100.5,97.8,102.1,99.5,100.0,98.9,101.5
TAB-CU-2026-002,95.0,105.0,92.0,108.0,96.0,104.0,93.0,107.0,94.0,106.0
TAB-FAIL-2026-003,80.0,120.0,85.0,115.0,82.0,118.0,83.0,117.0,81.0,119.0

FS — Functional Specification

Example output.json

{
  "utilityId": "content-uniformity-acceptance-value",
  "utilityName": "Content_Uniformity_Acceptance_Value",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TAB-CU-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit1%",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit2%",
      "value": "101.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit3%",
      "value": "99.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit4%",
      "value": "100.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit5%",
      "value": "97.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit6%",
      "value": "102.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit7%",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit8%",
      "value": "100.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit9%",
      "value": "98.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Unit10%",
      "value": "101.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "generatedFor": "QA/QC review and LIMS integration"
}

Traceability matrix

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator, documentation and test set.
• Retain input.csv, output.json, executable version, documentation and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits must be verified against the approved specification, local SOPs and registration dossier.