Report for Validation of Visual Inspectors

1. Verification of Training Record and Medical Checkup

Sr. No.	Name of Person	Training Status	Medical Checkup
			Done on	Due on
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2
3
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5
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7
8
9
10
Prepared By Sign / Date		Verified By Sign/Date

2. Verification of Light Intensity

Date:

Sr. No.	Side of visual inspection*	Light Intensity				Remark
		Black background	white background	On conveyor belt	Acceptance Criteria
1	LHS-1				NLT 2000 Lux
2	LHS-2
3	RHS-1
4	RHS-2

3. Verification of Visual Inspection Conveyor Speed with Stopwatch

Date:

Sr. No.	Side of visual inspection*	Conveyor			No of vial pass	Acceptance Criteria	Remark
		Start time	Stop time	VFD speed
1	LHS-1					NMT 80 vials/minute
2	LHS-2

*Having two visual inspection conveyor belt one side, this is controlled through one VFD

Checked By                                                                       Verified By

Sign /Date                                                                         Sign /Date

4. Verification of Pre-identified and Recorded Visual Inspection Defect

Random numbers shall be mentioned on the flip-off seal of all vials (rejects/good), & rejected vials numbers shall be mentioned in the below table for each set of inspection kits.

Product Name	Batch No.						Target fill Weight
Vial Size*	7.5 ml	10 ml	15 ml	20 ml	30 ml	Seal Colour

* Inspection kit shall be prepared for each vial size.

Type of Defect

Sr. No.	Name of defect	Required Qty/Set	Minimum Defect Criteria	Serial number allotted to defect/reject
				Inspection kit - 1	Inspection kit - 2	Inspection kit - 3
1	Crimping Seal rejection	1	Roughness at sealing
2	Molding defect	1	As per PDA
3	Cracks on vial	1	Minor Crack
4	Shape variation	1	Minor Variation in vial
5	Glass Piece in side vial	1	Approx 2 mm of glass piece
6	Seal colour	1	Minor discolor from actual product seal colour
7	Low weight	1	-25 % of target Fill weight:
8	High weight	1	+ 25 % of target Fill weight:
9	Empty Vial	1	Without Powder Vial
10	Other foreign particles inside the vial	1	Black particle in Vial

Checked By                                           Verified By

4. Verification of Pre-identified and Recorded Good vial

a. Verification of pre-identified and recorded good vial of dry powder injection (online)

No. of Set	Number of good vials	Observation	Observed By
Inspection kit – 1	90 vials
Inspection kit – 2	90 vials
Inspection kit – 3	90 vials

Prepared By:                                                Checked By:

b. Verification of pre-identified and recorded good vial of reconstituted vials (offline)

No. of Set	Number of good vials	Observation	Observed By
Inspection kit – 1	90 vials
Inspection kit – 2	90 vials
Inspection kit – 3	90 vials

Prepared By:                                                Checked By:

c. Verification of pre-identified and recorded good vial of empty vials

No. of Set	Number of good vials	Observation	Observed By
Inspection kit – 1	90 vials
Inspection kit – 2	90 vials
Inspection kit – 3	90 vials

Prepared By:                                                Checked By:

ALSO READ: Differences between Calibration, Verification and Validation

5. Observation of Visual Inspection

a. For Dry Powder: Inspection

I. Cleaned Empty Vials:

Name of Visual Inspector :

Designation :                                                         Date:

SET – I			SET – II			SET – III
Bottle No.	Status	Bottle No.	Bottle No.	Status	Bottle No.	Bottle No.	Status	Bottle No.
1
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5
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9
10

Summary Section

	SET – I	SET – II	SET – III
Good Bottles
Rejected Bottles
Done by
Checked by

Results: Pass / Fail:

Note: 

CN= Cracked in neck, 

GP =Glass Piece in Vials 

MD= Mold defect, 

BP= Bumps in bottom, 

CB= Chipped body, 

BN= Broken neck , 

Bb= Bubbles in Vials, 

BE = Broken edge, 

FP= Foreign particle details.

Evaluated By                                                Approved By

Sign & Date                                                   Sign & Date

II. Filled Vials:

Name of Visual Inspector :

Designation :                                                         Date:

SET – I			SET – II			SET – III
Bottle No.	Status	Bottle No.	Bottle No.	Status	Bottle No.	Bottle No.	Status	Bottle No.
1
2
3
4
5
6
7
8
9
10

Summary Section

	SET – I	SET – II	SET – III
Good Bottles
Rejected Bottles
Done by
Checked by

Results: Pass / Fail:

Note: 

Note: 

GV=Good vial, 

SR=Crimping Seal rejection, 

MV= Molded vial, 

CV= Cracked vial, 

SV= Shape variation 

GP=Glass Piece in side vial, 

SC=Seal colour, 

LW=Low weight, 

HW=High weight, 

EV =Empty Vial, 

FP=Foreign Particle

Evaluated By                                                Approved By

Sign & Date                                                   Sign & Date

6. Deviation, Change Control and Corrective Action

Deviation:

Change Control:

Corrective Action:

Compiled By	Verified By
Sign & Date	Sign & Date

ALSO READ: Protocol for Validation of Visual Inspectors