🇲🇾 NPRA — Pusat Kawalan Kualiti · ISO/IEC 17025 Accredited

◈ Seksyen Pengujian Produk & Kosmetik · Unit Penyaringan

PKKK/300/UP/064 Control Charting & Trend Analysis - 5 Jun 2026

Arahan Kerja Rasmi (Level 300 SOP) · Kategori: Kawalan Kualiti & QA

1. Persediaan

Penerimaan sampel & borang

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2. Pelaksanaan

Langkah kerja mengikut SOP

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3. Verifikasi

Pemeriksaan kualiti & pematuhan

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4. Dokumentasi

Perekodan fail kualiti rasmi

⚡ Spesifikasi & Parameter Kromatografi / Analitikal (Official Parameters):

Instrumen UtamaSistem Kawalan Kualiti Statistik & Carta Kawalan Shewhart

Kriteria Kesesuaian Sistem (SST)Amaran Tindakan: 1 titik di luar had ±3s (UCL/LCL), atau 2 daripada 3 titik berturutan di luar had ±2s (UWL/LWL).

💡 Petua & Perhatian Penting Makmal (Bench Notes):

Patuhi amalan keselamatan makmal yang baik (GLP) dan rekodkan semua langkah persediaan dalam lembaran kerja rasmi.
Sebarang ketakakuran atau sampel luar spesifikasi hendaklah disiasat mengikut Arahan Kerja PKKK/300/UP/002.

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NPRA PUSAT KAWALAN KUALITI	ARAHAN KERJA: CONTROL CHARTING & TREND ANALYSIS - 5 JUN 2026
	No. Dokumen: PKKK/300/UP/064	Terbitan / Semakan: Terbitan 3 Semakan 0
	Tarikh Kuatkuasa: 10 April 2026	Bahagian / Unit: SPPK · Unit Penyaringan

0.0 SEJARAH PINDAAN & SEMAKAN 2.0 SCOPE 3.0 DEFINITIONS 4.0 FLOW CHART 6.0 PROCEDURE 7.0 QUALITY RECORDS 📊 Jadual Data (3)

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0.0 SEJARAH PINDAAN & SEMAKAN

PURPOSE

This procedure provides guidance in carrying out control charting and trend analysis as an essential tool for quality control.

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2.0 SCOPE

This document shall be used by Screening Unit, Product and Cosmetic Testing Section, Centre for Compliance and Quality Control, National Pharmaceutical Regulatory Agency to plot and analyze accuracy and precision control charts for Internal Quality Control (IQC) Samples.

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3.0 DEFINITIONS

Internal Quality Control (IQC) Sample - a pre-selected routine sample with no or low intrinsic analyte concentration that is spiked at level of interest. It is used to evaluate bias (and precision, if prepared in duplicate) of the method as influenced by a specific sample matrix

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4.0 FLOW CHART

Please refer to the flow chart below

RESPONSIBILITY

Pharmacist

5.1.1 To ensure IQC Sample data is collected and control charts are prepared following this procedure

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6.0 PROCEDURE

Control Charting

Accuracy control chart for IQC Samples

Langkah 1 Collect at least 10 accuracy data on 10 different days (with acceptable % Recovery and % RPD e.g. % Recovery = 80 - 115%, % RPD < 20%)

Calculate the mean, m and standard deviation, sd of the accuracy data

Langkah 2 Set the mean, m as the central line, warning limits as m ± 2sd, and control limits as m ± 3sd. Refer Appendix 1, Figure 1.

Langkah 3 Enter data into the chart each time IQC Samples are analyzed

For IQC Sample that is prepared in duplicate, choose only one sample randomly, e.g. by taking only the lower or the higher reading always, or only IQC Sample A or B always etc.

Precision control chart for duplicate samples

Langkah 4 Set zero as the baseline. Estimate a standard deviation, sd from the repeatability limit of the method using equation below:

Repeatability limit = 2 x √2 x sd

sd = Repeatability limit / 2.828

Calculate the central line and upper warning limit from the estimated sd using equations below.

Central line = 1.128 x sd

Upper warning limit = 2.833 x sd

Langkah 5 Set the central line and upper warning limit in the chart. Refer to Appendix 1, Figure 2.

Langkah 6 Enter precision data (% Relative Percent Difference of duplicate) into the chart each time the IQC Samples are analyzed

Trend Analysis

Refer to flow chart

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7.0 QUALITY RECORDS

APPENDIX 1

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Jadual Kromatografi & Rujukan Data

JADUAL 1 PKKK/300/UP/064

HISTORY OF REVISION	HISTORY OF REVISION	HISTORY OF REVISION	HISTORY OF REVISION	HISTORY OF REVISION	HISTORY OF REVISION
Issue	Revision	Written by	Reviewed by	Approved by	Effective date
1	0	Nurul ‘Izzah Hany Ismail	Tan Lu Yi	Ida Syazrina Ibrahim	5 June 2026

JADUAL 2 PKKK/300/UP/064

REFERENCE	REFERENCE
Dokumen no.	Title
PKKK/200/027	Ensuring The Validity of Test Results
-	Standard Methods for the Examination of Water and Wastewater 1999 by American Public Health Association (Section 3020B: Quality Control Practice & Section 1020B: Quality Control)
-	Handbook of Internal Quality Control, Nordtest Report TR 569 Edition 5

JADUAL 3 PKKK/300/UP/064

NO.	TITLE	FORM NO.
7.4	Borang Corrective Action in Control Charting	UP0/012