CHECKER VALIDATION PROTOCOL AND REPORT FOR CAPSULE VISUAL INSPECTION

VALIDATION TEAM:

Designation Name Signature Date
QA Officer      
Production Chemist      
Production Manager      
QA Manager      
Name of Visual Inspector  
Date of Commencement  
Date of Completion  
Training Done Yes                                                    No
Date of Training  
Used Capsules Shell Oval                                               Oblong
Used Colour of Capsules  
Signature of Visual Inspector / Date  
  1. IDENTIFICATION OF REJECTED CAPSULES:

Date: _______________

Type of Rejected Capsules Observation Remark
Banana Shape Yes           No  
Empty Capsules      Yes              No  
Leak Capsules Yes               No  
Under sized Shape    Yes              No  
Over size Capsules       Yes              No  
D-Shaped Capsules    Yes              No  
  • MAXIMUM DURATION OF INSPECTION ON DIFFER DAYS

Date: _______________

Time Qty. Used for Observation Rejected Capsules Remarks
For 1 Hours      
For 2 Hours      
For 3 Hours      
For 4 Hours      

Date: ______________

Time Qty. Used for Observation Rejected Capsules Remarks
For 1 Hours      
For 2 Hours      
For 3 Hours      
For 4 Hours      

Date: _____________

Time Qty. Used for Observation Rejected Capsules Remarks
For 1 Hours      
For 2 Hours      
For 3 Hours      
For 4 Hours      
  • MAXIMUM SPEED OF INSPECTION ON DIFFER DAYS

Date: _______________

No. of Capsules check Rejected Capsules Time Duration Capsule / Hours Remarks
           
           
           
Average of Capsule / Hours  

Date: ______________

No. of Capsules check Rejected Capsules Time Duration Capsule / Hours Remarks
           
           
           
Average of Capsule / Hours  

Date: ______________

No. of Capsules check Rejected Capsules Time Duration Capsule / Hours Remarks
           
           
           
Average of Capsule / Hours  
  • QUALITY OF INSPECTION ON DIFFER DAYS

Date: _______________

No. of Capsules check Rejected Capsules Time Duration Observed Rejected Capsules Remarks
1000 Capsules 10 Capsules        
1000 Capsules 10 Capsules        
1000 Capsules 10 Capsules        

Note: Minimum 9 rejected capsules should be recovered.

Date: ______________

No. of Capsules check Rejected Capsules Time Duration Observed Rejected Capsules Remarks
1000 Capsules 10 Capsules        
1000 Capsules 10 Capsules        
1000 Capsules 10 Capsules        

Note: Minimum 9 rejected capsules should be recovered.

Date: ______________

No. of Capsules check Rejected Capsules Time Duration Observed Rejected Capsules Remarks
1000 Capsules 10 Capsules        
1000 Capsules 10 Capsules        
1000 Capsules 10 Capsules        

Note: Minimum 9 rejected capsules should be recovered.

Remarks: ________________ is validated / does not validate for visual inspection of Softgel capsules.

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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