DAXIN PHARMACEUTICALS PVT. LTD.

BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 1 of 8

Protocol
For
Validation of Visual Inspectors

Protocol No. DPPL/ PVVI-001-00

Revision No. 00

Supersede No. NIL

Effective Date 20/03/2024

No. of Pages 8

Format No:-DPPL/QA-062-00
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 2 of 8

1. Table of Contents
SR. NO. TITLE PAGE NO.

--- Cover page 1

1.0 Table content 2

2.0 Protocol approval 3

3.0 Validation team and responsibilities 4

4.0 Objective 5

5.0 Purpose 5

6.0 Training & qualification status of personnel 5

7.0 Pre validation Requirement 5

8.0 Selection and preparation of visual inspection Kit 5

9.0 Validation Procedure 6-7

10.0 Acceptance Criteria 7

11.0 Re-validation criteria 7

12.0 Validation report 7

13.0 Evaluation and approval of validation report 8

14.0 List of Annexure 8

15.0 Reference Document 8

16.0 Revision History 8

17.0 Annexure 9-27

2.0 PROTOCOL APPROVAL

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 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 3 of 8

Function Department Name Designation Sign & Date

Prepared By Quality Assurance

Production

Reviewed By

Quality Assurance

Approved by Quality Assurance

3.0 Validation Team and Responsibilities:

Format No:-DPPL/QA-062-00
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 4 of 8

DEPARTMENT NAME DESIGNATION SIGN DATE

PRODUCTION
VALIDATION
TEAM
QUALITY
ASSURANCE

DEPARTMENT RESPONSIBILITIES

• Checking of protocol.
• Execution of protocol along with IPQA team.
PRODUCTION • Identification of visual inspectors & give them training
for visual inspection.
• Maintaining record of inspection machine & intensity
verification.
• Preparation & Maintaining Inspection Kit.
• Preparation of protocol
• Execution of protocol with’ co-ordination of production
departments.
QUALITY
• Review & compilation of reports.
ASSURANCE
• Review & Approval of protocol & Report

4.0 Objective:

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 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 5 of 8

The objective of this protocol is to validate performance of visual inspectors

/supervisors.

5.0 Purpose:
Purpose of this protocol is to ensure, that visual inspectors are capable to
detect and remove units of drug product with predefined defects in a
reproducible manner in a controlled process consistently during routine
manufacturing & packing operation of tablets, capsules, ointment, liquid &
dry powder injection.

Procedure laid by this protocol shall be applicable for performance

evaluation of visual inspectors involve for inspection of coated tablets &
packed units during packing at Daxin Pharmaceuticals Pvt. Ltd.

6.0 Training & Qualification status of personnel:

Visual inspector for different types of rejection or check points during visual
inspection such as scratches on vial surface, damaged vial, wrinkled seal,
dirty Vials, loose seal, dented seal, empty Vials, excess aluminum on seal,
color uniformity of seal, foreign particle, powder color uniformity, Defects
related to the coated tablets include: Colour variation, broken tablet,
Twinning, Roughness, and Chipping. Mottling, Thickness variation,
cracking, sticking & picking.

Training& qualification status of the person involved in validation of visual inspectors

shall be verified & recorded in Annexure I.
7.0 PRE-VALIDATION REQUIREMENTS:
 Eye check up for visual inspectors and supervisors.
 Training records.
 Inspection bench with black and white background.
 Visual inspection Kit.
 Light intensity NLT 2000 Lux level.

Format No:-DPPL/QA-062-00
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 6 of 8

8.0 SELECTION / PREPARATION OF VISUAL INSPECTION KIT:

As per analysis on deviations, complaints, production rejection, defected vials shall be
selected for including it in the inspection kit. 10% defective vials shall be mixed with good
vials to make an inspection Kit for each vial size i.e. 7.5 ml 10ml, 15 ml, 20ml, 30 ml and
record.

Visual inspection kit shall be prepared by person who have good knowledge &
understanding of various type of defects & rejects & able to train operators / supervisor on
visual inspection process & defects / rejects

9.0 Validation procedure:

Procedure for validation of inspector's for Inspection of Coated tablets:

Identify the coated tablet of that product in which either there is maximum chance to
observe the defect or in which it's very tough to identify the defects or the whole process
of observing the defect is assiduous or it may be the exercise of both.
 Take pre identified 10 visuals defected and 90
good tablets of same products.
 Mix the defected tablet & the good coated tablet
 Set the inspection conveyor speed adequate to visual inspection of tablets. Verify
the speed with help of stop watch & record details in Annexure-I. Operator shall
start inspecting the tablets.
 Put the tablet from the inspection kit on the running conveyor belt.
 Visual inspector has to identify the rejected or defected tablet like Colour
variation, broken tablet, Laminated tablets, Twin Sticking tablets, Rough Edges,
Chipping. Mottling, Thickness variation, Black particles and other foreign
particles.

9.1 Online visual inspection of dry powder injection:

9.1.1 Take pre identified 10 visuals rejects and 90 good vials.
9.1.2 Mix and keep them on turn table.
9.1.3 Set the turn table rotational speed adequate to feed visual inspection machine at rate of 80
vials per minute.
9.1.4 Visual inspection machine shall be set at 80 vials per minute speed. Verify the speed with
help of stop watch & record ..

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 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 7 of 8

9.1.5 Put the vials from inspection kit on turn table & allow feed it on visual inspection
machine.
9.1.6 Operator/Casual worker shall start inspecting the vials.
9.1.7 He has to identify the rejects like glass particles, sealing rejects, black particles and
colour variation of powder and physical defects of vials, seals.
9.1.8 Segregate the rejects and good as per the inspector’s observations and record the same.
9.1.9 Continue the same process for three times and record the same.
9.1.10 At the end, verify the %age of rejects identified by the inspector. If they have
missed to identify any rejects, reject details shall be explained & again inspector shall ask
to perform the inspection & identify the rejects.
9.1.11 If any Operator/Casual worker missed to identify the rejects in second chance also,
he should not be qualified for visual inspection of vials.
9.2 Off-line visual inspection of reconstituted vials:
9.2.1 Take pre identified 10 visual rejects after reconstitution and 90 good reconstituted vials.
9.2.2 Mix the vials and allow the supervisor for inspection.
9.2.3 Supervisor shall inspect the vials on black background and white background for
particulate matter.
9.2.4 For black background he has to check white particles, glass particles, fibers.
9.2.5 For white background he has to check black particles.
9.2.6 Segregate the rejects and good vials as per the observations of inspector and record the
same.
9.2.7 At the end, verify the %age of rejects identified by the inspector. If they have missed to
identify any rejects, reject details shall be explained & again inspector shall ask to
perform the inspection & identify the rejects.

9.2.8 If any Operator/Casual worker missed to identify the rejects in second chance also, he
should not be qualified for visual inspection of vials.

9.3 Off –Line Visual Inspection of Empty Vial:

9.3.1 Take pre identified 10 visual empty defect and 10 shrink of empty vial.
9.3.2 Mix one defected vials in each shrink and ask visual inspector for inspection.
9.3.3 Inspection shall be done on black background and white background.

Format No:-DPPL/QA-062-00
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI , H.P.

Title Protocol For Validation of Visual Inspectors

Protocol no . DPPL/ PVVI-001-00 Page 8 of 8

9.3.4 For black background he has to check white particles, glass particles, fibers.
9.3.5 For white background he has to check black particles.
9.3.6 Segregate the defect and good vials as per the observations of inspector and record the
same.
9.3.7 At the end, verify the %age of rejects identified by the inspector. If they have missed to
identify any rejects, reject details shall be explained & again inspector shall ask to
perform the inspection & identify the rejects.
9.3.8 If any operator missed to identify the rejects in second chance also, he should not be
qualified for visual inspection of vials.

10.0 ACCEPTANCE CRITERIA:

Visual inspector shall identified rejected and good vials simultaneously in both
procedures. If any Operator/Casual worker (pre-qualified) does not qualify as a visual
inspector, it shall be investigated & impact assessment shall be done& summary report
shall be prepared as per Annexure 1.

Visual inspectors and supervisors should be qualified in eye test (near, far & colour
Vision) by registered Medical officer.

11.0 RE-VALIDATION CRITERIA :

Re-validation of visual inspectors shall be done every year and / or if he

resumes work after leave of more than 30 days or after any illness of more
than 7 days.

12.0 Validation Report

The Validation report shall consist of a summary of activity performed & their
observation recorded in relevant exhibits which were completed during
qualification activity.
13.0 Evaluation and Approval of Validation Report
The report shall be evaluated and proper references / conclusions /
recommendations shall be recorded by validation team. The validation report
shall be finally approved by Head of Quality Assurance.
14.0 List of Annexure
The Validation report shall be prepared as per Annexure-I.
15.0 Reference Documents (If any)
NA

Format No:-DPPL/QA-062-00