QC.

O02
Revision 1.0
01.09.2021

QC Test Method (Output Febrile Inspection)

1.0 Test Codes
1.1. QC.O02

2.0 Test Name

2.1 Output Febrile Inspection

3.0 QC Point
3.1 Output: Post-production activities

4.0 Reference
4.1 Inspection Work Instruction (PR-QC-PI03)
4.2 Sampling table (PR-QC-PD01)
4.3 Dispense order (PR-PR-PR02)
4.4 Item dispense (PR-WH-PR02)

5.0 Type:
5.1 In-House.

6.0 Tools-Materials and Equipment's.

6.1 Reaction slide.
6.2 Stirring sticks.
6.3 Timer.
6.4 Febrile reagent.
6.5 Febrile antigen positive control.
6.6 Febrile antigen negative control.
6.7 Febrile factors

7.0 Required Form

Code Required forms
QC.09F Febrile Inspection Form
QC.02F General Inspection Form
PR-QC-PR01 QC sampling inspection Form

8.0 Inspection and Testing method

8.1. QC Officer: Obtain samples according to the Inspection Work Instruction (PR-QC-PI03) and conduct
physical inspection and biochemical.
8.2. QC Officer: Conduct physical inspection as per acceptance criteria (not limit to) as listed in the Table 1.
Record the result in the Febrile Inspection Form (QC.09F) and QC Sampling Inspection Form (PR-QC-
PR01).

Process Parameters Acceptance Criteria

• Verify the colour and status referring to the Table 2 (Reagent colour
Colour and
and status)
status
• Check the size as follows:
Filling Weighted one vial/bottle with requested volume as standard to check the
size of filled vial/bottle by vision. The standard volume should follow
Reagent size as per requested in item dispend, for example 5mL volume The standard
vial needs to change weekly.
Note: The acceptance criteria: The volume level of filled vial should
even/same as the standard volume level.
Closing Closing cap • Closing the cap and invert the vial to check that the vial is closed well
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and there is no leakage.

• Verify the label information is correct
Labelling Labels • Check the label orientation and position at the correct place
• Check the label printing to make sure it is clear and readable
• Check the packaging material type (box/vacuum pack/holder/etc)
Packaging which need to match with the dispense order.
material • Match the brand of the packaging material with the dispense order
(PR-PR-PR02)
• Check the package insert printing and folding are correct.
• Check the product name, brand, code, and version as mentioned in
Package Insert
item dispense.
Packaging • Match the address in the package insert with the address mentioned
(If on box design.
applicable) • Check the physical condition as follow:
Glass slide
- No scratch in test circles, edges, and glass slide bottom.
- There is nothing broken or damaged.
• Check the physical condition as follow:
Stirring stick
- Clean
- No breaking stick
Kit component • Check the component and quantity of the kit are present as per item
and quantity dispense (PR-WH-PR02)

Table 1: Acceptance criteria for the physical inspection

Reagent Colour Status

Salmonella OA Dark blue Liquid
Salmonella OB Dark blue Liquid
Salmonella OC Dark blue Liquid
Salmonella OD/OT Dark blue Liquid
Salmonella HA Dark red Liquid
Salmonella HB Dark red Liquid
Salmonella HC Dark red Liquid
Salmonella HD/HT Dark red Liquid
Brucella Abortus Dark blue Liquid
Brucella Melitensis Dark blue Liquid
Rose Bengal Dark Pink Liquid
Proteus Dark blue Liquid
Proteus Polyvalent control Yellowish Liquid
Rose Bengal Positive Control Yellowish Liquid
Universal negative control Yellowish Liquid
Table 2: Reagent Colour and status

8.3. QC Officer: Conduct biochemical inspection. The tests involved in biochemical inspection as per listed
below:
A. Inspection using controls
B. Inspection using febrile antiserum factors.

A) Inspection using control

1. Bring the reagent to the room temperature and mix well.

2. Add one drop each of febrile reagent on two separate circles of the white glass slide
3. Add the positive control and negative control on each circle respectively

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4. Mix the reagent and the control using a clean stirring stick over an area with a diameter of
approximately 20-40mm
5. Rotate the slide for respective times as Table 3 below:

Item name Rotation time (min)

Salmonella OA 1
Salmonella OB 1
Salmonella OC 1
Salmonella OD 1
Salmonella HA 1
Salmonella HB 1
Brucella Abortus 1
Brucella Melitensis 1
Proteus Antigen 1
Brucella Rose Bengal 4
Table 3: The rotation time for each reagent

6. Read the results immediately by observing any visible agglutination in good indirect light Record the
time of agglutination and read the result based on the acceptance criteria as Table 4 below.

Item Name Positive Negative

Give agglutination
Salmonella OA No agglutination
Intensity (+1) Or (+2)
Give agglutination
Salmonella OB No agglutination
Intensity (+1) Or (+2)
Give agglutination
Salmonella OC No agglutination
Intensity (+1) Or (+2)
Give agglutination
Salmonella OD No agglutination
Intensity (+1) Or (+2)
Give agglutination
Salmonella HA No agglutination
Intensity (+1) Or (+2)
Give agglutination
Salmonella HB No agglutination
Intensity (+1) Or (+2)
Give agglutination
Brucella Abortus No agglutination
Intensity (+1) Or (+2)
Give agglutination No agglutination
Brucella Melitensis
Intensity (+1) Or (+2)
Give agglutination
Proteus Antigen No Agglutination
Intensity (+1) Or (+2)
Give agglutination
Brucella Rose Bengal No Agglutination
Intensity (+1) Or (+2)
Table 4: The acceptance criteria of agglutination intensity using controls

7. Record the result on Febrile Inspection Form (QC.09F) and QC Sampling Inspection Form (PR-QC-
PR01). Attach them to production batch.
Note: For controls product, record the results on General Inspection Form (QC.02F) and QC
Sampling Inspection Form (PR-QC-PR01). Attach the two forms with related production batch.

B) Inspection using febrile antiserum factors (applicable for salmonella reagent only)

1. Add one drop of febrile on four circles of the white glass slide
2. Add the factors on each circle respectively.

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3. Mix the reagent and the control using a clean stirring stick over an area with a diameter of approximately
20-40mm
4. Rotate the slide for 1 min.
5. Read the results immediately by observing any visible agglutination in good indirect light. Record the
time of agglutination and read the results based on the acceptance criteria as Table 5 below.

Type of factors Acceptance criteria

Factor a Give Agglutination with HA
Intensity (+1) Or (+2)
Factor b Give Agglutination with HB
Intensity (+1) Or (+2)
Factor c Give Agglutination with HC
Intensity (+1) Or (+2)
Factor d Give Agglutination with HD
Intensity (+1) Or (+2)
Factor O2 Give Agglutination with OA and HA
Intensity (+1) Or (+2)
Factor O4 Give Agglutination with OB
Intensity (+1) Or (+2)
Factor O7 Give Agglutination with OC
Intensity (+1) Or (+2)
Factor O9 Give Agglutination with OD
Intensity (+1) Or (+2)
Table 5: Acceptance criteria for test using antiserum factor
6. Record and update the result on Febrile Inspection Form (QC.09F) and QC Sampling Inspection
form (PR-QC-PR01). Attach them to the production batch.

8.4. QC Officer: Update the result in the ERP system as follow:

8.4.1. Open the ERP system, then go to the “finished product delivery” screen under “production tab”
8.4.2. Key in the batch lot number and press enter
8.4.3. Under “Quality control” section, key in the “proforma number” and the “finished quantity” of the batch,
then press enter\
8.4.4. Click “Yes” (for accepted batch) or “No” (for rejected batch), at the “QC in-process” & “QC Released”
to release the product.
8.5. QC Officer: Record the results on Febrile Inspection Form (QC.09F) and update QC Sampling Inspection
Form (PR-QC-PR01). Attach the two forms with related production batch.
8.6. QC Officer: Stamp the released batch with QC released stamp on QC Sampling Inspection Form (PR-QC-
PR01).
8.7. QC Officer: Call warehouse officer to receive the released product.

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