デフォルトの QC テスト定義

QC テスト

レポート値式

テスト合格条件式

ICB

MeasuredConc

abs(ReportValue) <= CRQL

CCB

MeasuredConc

abs(ReportValue) <= CRQL

ICV

MeasuredConc / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

CCV

MeasuredConc / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

LCS

MeasuredConc / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

MSPK

(MeasuredConc - MeasuredConc(PreviousSample)) / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

MSD

マトリックススパイク

(MeasuredConc - MeasuredConc(PreviousSample)) / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

複製

abs(MeasuredConc(MSPK) - MeasuredConc) / ((MeasuredConc(MSPK) + MeasuredConc) / 2) * 100

(ReportValue < PercentDiff) or (MeasuredConc < 5 * CRQL)

DUP

abs(MeasuredConc(PreviousSample) - MeasuredConc) / abs((MeasuredConc(PreviousSample) + MeasuredConc) / 2) * 100

(ReportValue < PercentDiff) or (MeasuredConc < 5 * CRQL)

CRS

MeasuredConc / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

PBLK

MeasuredConc

abs(ReportValue) <= CRQL

SER

abs(MeasuredConc(PreviousSample) - MeasuredConc) / MeasuredConc(PreviousSample) * 100

(ReportValue < PercentDiff) or (MeasuredConc(PreviousSample) < 50*MDL)

QCSPK

(MeasuredConc - MeasuredConc(PreviousSample)) / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

ICSA

MeasuredConc/DefinedConc * 100

(MeasuredConc >= min(DefinedConc*LowerLimit/100, DefinedConc-CRQL)) and (MeasuredConc <= max(DefinedConc*UpperLimit/100, DefinedConc+CRQL))

ICSAB

MeasuredConc/DefinedConc * 100

(MeasuredConc >= min(DefinedConc*LowerLimit/100, DefinedConc-CRQL)) and (MeasuredConc <= max(DefinedConc*UpperLimit/100, DefinedConc+CRQL))

SSUM

Average(MeasuredConc)

((ReportValue/DefinedConc * 100)>= LowerLimit) and ((ReportValue/DefinedConc * 100) <= UpperLimit)

RINSE

N/A

1 > 0

QC テスト

レポート値式

テスト合格条件式

すべての QC サンプル**

MeasuredConc / DefinedConc* 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

成分 - 吸入

InhalationalComponent

ReportValue > = MeasuredConc

成分 - 経口

OralComponent

ReportValue > = MeasuredConc

成分 - 非経口

ParenteralComponent

ReportValue > = MeasuredConc

コントロールのしきい値 - 吸入

(InhalationalProduct / ((Volume / Weight) * Dilution * MMD)) * 0.3

ReportValue > = MeasuredConc / ((Volume / Weight) * Dilution)

コントロールのしきい値 - 経口

(OralProduct / ((Volume / Weight) * Dilution * MDD)) * 0.3

ReportValue > = MeasuredConc / ((Volume / Weight) * Dilution)

コントロールのしきい値 - 非経口

(ParenteralProduct / ((Volume / Weight) * Dilution * MDD)) * 0.3

ReportValue > = MeasuredConc / ((Volume / Weight) * Dilution)

LSpike (L1)、LSpike (L2)、LSpike (L3)

(MeasuredConc - MeasuredConc(Previous Sample)) / DefinedConc * 100

(ReportValue >= LowerLimit) and (ReportValue <= UpperLimit)

製品 - 吸入

(InhalationalProduct / ((Volume / Weight) * Dilution * MMD))

ReportValue > = MeasuredConc / ((Volume / Weight) * Dilution)

製品 - 経口

(OralProduct / ((Volume / Weight) * Dilution * MDD))

ReportValue > = MeasuredConc / ((Volume / Weight) * Dilution)

製品 - 非経口

(ParenteralProduct / ((Volume / Weight) * Dilution * MDD))

ReportValue > = MeasuredConc / ((Volume / Weight) * Dilution)