IQC for Quality Assurance n n QA sample

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IQC for Quality Assurance n n QA sample series ������� (������ ) ��������������� QA

IQC for Quality Assurance n n QA sample series ������� (������ ) ��������������� QA sample series ������������������� QA sample series: - ����� Negative control, Positive control & Blind sample QA sample series ���� QA series �����������������������

IQC for Quality Assurance �������� n Control Sample (Quality Assurance Sample series) – Negative

IQC for Quality Assurance �������� n Control Sample (Quality Assurance Sample series) – Negative sample (Blank: - Reagent/Matrix) – Positive sample (Recovery) – Blind sample n Control Limit/Criteria ����� %Recovery ������ n Control Chart ��������������

Control Sample: - Recovery n Positive sample (Recovery) – Recovery Sample ������������������ Tips –

Control Sample: - Recovery n Positive sample (Recovery) – Recovery Sample ������������������ Tips – ������������

Control Sample (Quality Assurance Sample Series) n Blank sample: – Reagent Blank ������������������������ (Tacit

Control Sample (Quality Assurance Sample Series) n Blank sample: – Reagent Blank ������������������������ (Tacit K) – Matrix Blank: ����� 1 ������� ������������������������ (Tacit K) n Recovery sample: duplicate, – 1 or 2 levels (������ MRL, ½ MRL) n Blind sample: duplicate,

Control Limit/Criteria for analytical chemistry (Rt, Accuracy, Precision, Reproducibility, Ion ratio of mass fraction)

Control Limit/Criteria for analytical chemistry (Rt, Accuracy, Precision, Reproducibility, Ion ratio of mass fraction) Codex vs EU Commission Decision 2002/657 Tips (Tacit K) ����������� ������� ������ (������� ( )����������������������

Control Limit/Criteria for analytical chemistry Example n Retention time (HPLC technique) – 2. 5%

Control Limit/Criteria for analytical chemistry Example n Retention time (HPLC technique) – 2. 5% ���� 6 0. 15 min (5. 85 ��� 6. 15) – 0. 1 min ���� 6 0. 1 (5. 9 ��� 6. 1) n Accuracy, Precision (% CV) ���� – 70 -110% (����� ) 90 -110% – %CV < 23 % vs as low as possible

Control Chart ���������� plot ���� n ���������� ��� % recovery n ��� 2 SD

Control Chart ���������� plot ���� n ���������� ��� % recovery n ��� 2 SD = warning limit (UWL/LWL) n 3 SD = Control limit (UCL/LCL) > 2 SD investigate & corrective action > 3 SD STOP/reject & [investigate & corrective action] n ������ plot ���� :

Conclusion Evaluation of each parameters of QA sample : PASS n PASS assure the

Conclusion Evaluation of each parameters of QA sample : PASS n PASS assure the quality of test results of samples in the same batch n – ��������������������� ���������� n “Test result” is correct and can be reported

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