STANDARD OPERATING PROCEDURE Title: IN PROCESS MONITORING

1. PURPOSE

1.1 To ensure quality system of products.

2. SCOPE

2.1 It is applicable to Quality Assurance and Quality Control Department.

3. RESPONSIBILITY

3.1 Quality Control Manager

3.2 Quality assurance Officer

4. PROCEDUR

ENCAPSULATION CHECK

1. General Cleaning of Area, Machinery/Equipment of Container etc.

2. Control of Weight Variation

3. Humidity Control

4. General Cleaning of Machinery / Containers & area.

5. Document Control

MIXING/GRANULATION CHECK

1. General Cleaning of Area, Machinery/Equipment of Container etc

2. Humidity Control

3. Process Control

4. Document Control

COMPRESSION CHECK

1. General Cleaning of Area, Machinery/Equipment of Container etc

2. Weight variation control

3. Disintegration and friability

4. Hardness

5. Humidity Control

6. Document Control

COATING CHECK

1. General Cleaning of Area, Machinery/Equipment of Container etc

2. Process Control

3. Solution making containers / stirrer

BLISTER/STRIP CHECK

1. Humidity checking

2. Process Control

3. Blister sealing

4. Blister cutting

5. Embossed Numbers/Printed batch No.

PACKAGING CHECK

1. General Check of area

2. Checklist

LIQUID FILLING CHECK

1. Volume filled

5. QUALITY RECORD(s)/FORM(s)

The following Quality Records shall be generated and managed in accordance with the procedure for Control of Company Quality Records (4.12).

Required Record	Form Reference No.
Temperature Humidity Daily/Weekly Record	QF/005/01
Check list for Packaging	QF/025/01
Weight Control Sheet Production	QF/019/01
Graph (For Weight Variation)	QF/129/01
Inprocess Monitoring Sheet	QF/124/01