TABLE OF CONTENT
- Protocol Approval
- Validation team and responsibilities
- Objective
- Purpose
- Training & qualification status of personnel
- Pre-validation Requirement
- Selection and preparation of visual inspection Kit
- Validation Procedure
- Acceptance Criteria
- Re-validation criteria
- Validation report
- Evaluation and approval of validation report
- List of Annexure
- Reference Document
- Revision History
1. PROTOCOL APPROVAL
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Function |
Department |
Name |
Designation |
Sign & Date |
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Prepared By |
Quality Assurance |
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Reviewed By |
Production |
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Quality Assurance |
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Approved by |
Quality Assurance |
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2. VALIDATION TEAM AND RESPONSIBILITY
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DEPARTMENT |
RESPONSIBILITIES |
|
PRODUCTION |
Checking of protocol. Execution of protocol along with the IPQA team. Identification of visual inspectors & giving them training for
visual inspection. Maintaining records of inspection machines & intensity verification. Preparation & Maintaining Inspection Kit. |
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QUALITY ASSURANCE |
Preparation of protocol Execution of protocol with co-ordination of production departments. Review & compilation of reports. Review & Approval of protocol & Report |
3. OBJECTIVE
The objective of this protocol is to validate the performance of visual inspectors/supervisors.
4. PURPOSE
The purpose of this protocol is to ensure that visual inspectors are capable of detecting and removing units of drug products with predefined defects in a reproducible manner in a controlled process consistently during routine manufacturing & packing operations of tablets, capsules, ointments, liquids & dry powders for injection.
The 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 PharmaGuide Pvt. Ltd.
5. TRAINING & QUALIFICATION STATUS OF PERSONNEL
Visual inspection for different types of rejection or check points during visual inspection, such as scratches on the vial surface, damaged vials, wrinkled seals, dirty vials, loose seals, dented seals, empty vials, excess aluminium on seals, colour uniformity of seals, foreign particles, and powder colour uniformity. Defects related to the coated tablets include colour variation, broken tablets, twinning, roughness, 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.
6. PRE-VALIDATION REQUIREMENTS
- Eye check-ups for visual inspectors and supervisors.
- Training records.
- Inspection bench with a black and white background.
- Visual inspection kit.
- Light intensity NLT 2000 Lux level.
7. SELECTION / PREPARATION OF VISUAL INSPECTION KIT
As per the analysis on deviations, complaints, production rejection, and defected vials, these 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, 10 ml, 15 ml, 20 ml, and 30 ml and record.
A 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
8. VALIDATION PROCEDURE
Procedure for validation of inspectors for inspection of coated tablets:
Identify the coated tablet of that product in which either there is a 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 the same products.
- Mix the defected tablet & the good coated tablet
- Set the inspection conveyor speed adequate for visual inspection of tablets. Verify the speed with the help of a stopwatch & record details in Annexure-I. The operator shall start inspecting the tablets.
- Put the tablet from the inspection kit on the running conveyor belt.
- The visual inspector has to identify the rejected or defected tablet, like colour variation, broken tablets, laminated tablets, twin-sticking tablets, rough edges, or chipping. Mottling, thickness variation, black particles and other foreign particles.
- Take pre identified 10 visuals rejects and 90 good vials.
- Mix and keep them on turn table.
- Set the turn table rotational speed adequate to feed visual inspection machine at rate of 80 vials per minute.
- Visual inspection machine shall be set at 80 vials per minute speed. Verify the speed with help of stop watch & record .
- Put the vials from inspection kit on turn table & allow feed it on visual inspection machine.
- Operator/Casual worker shall start inspecting the vials.
- He has to identify the rejects like glass particles, sealing rejects, black particles and colour variation of powder and physical defects of vials, seals.
- Segregate the rejects and good as per the inspector’s observations and record the same.
- Continue the same process for three times and record the same.
- 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.
- If any Operator/Casual worker missed to identify the rejects in second chance also, he should not be qualified for visual inspection of vials.
Visual inspection of reconstituted vials:
- Take pre identified 10 visual rejects after reconstitution and 90 good reconstituted vials.
- Mix the vials and allow the supervisor for inspection.
- Supervisor shall inspect the vials on black background and white background for particulate matter.
- For black background he has to check white particles, glass particles, fibers.
- For white background he has to check black particles.
- Segregate the rejects and good vials as per the observations of inspector and record the same.
- 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.
- If any Operator/Casual worker missed to identify the rejects in second chance also, he should not be qualified for visual inspection of vials.
Off –Line Visual Inspection of Empty Vial:
- Take pre identified 10 visual empty defect and 10 shrink of empty vial.
- Mix one defected vials in each shrink and ask visual inspector for inspection.
- Inspection shall be done on black background and white background.
- For black background he has to check white particles, glass particles, fibers.
- For white background he has to check black particles.
- Segregate the defect and good vials as per the observations of inspector and record the same.
- 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.
- If any operator missed to identify the rejects in second chance also, he should not be qualified for visual inspection of vials.
9. 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.
10. 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.
11. 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.
12. 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.
13. LIST OF ANNEXURE
The Validation report shall be prepared as per Annexure-I.
14. REFERENCE DOCUMENTS
NA
15. REVISION HISTORY
Nil
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