Performance Verification of Pharma code system
This article contains the Performance Verification of Pharma code system, Pharmacode is mainly used on the secondary packing material to identify the correct material and to avoid mixing as well.
Performance Verification protocol for Pharma code system
I: Objective:
To validate the Pharma code checking system by verifying that the component (or) system will function accordingly to the system specification.
II: Scope:
Applicable to Pharma Code checking.
III: Principle:
When carton comes in contact with the backlight of scanner of pharma code reader, scanner compares the pharma code with set reference Pharma code &
in case of wrong pharma code machine stops automatically.
IV: Justification for selection of item / process / product (formula) /storage condition:
V: Site of Study:
Pharma Packing
VI: Responsibility:
Representative from Production : ____________________________
Quality Assurance : ____________________________
Engineering : ____________________________
VII: Description of the Equipment to be used:
Equipment : Cartonator ·
CODE No : _________________
- Date of Equipment Qualification done _______________
Equipment : Pharma coding system ·
CODE No : _________________
- Date of Equipment Qualification done _______________
VIII: Standard Operating Procedure (SOP) to be followed:
SOP for operating cartonator SOP No. : ___________
SOP for operating Pharma coding system SOP No. : ___________
IX: Requirement:
SOP for operating Cartonator SOP No________________
SOP for operating Pharma coding system SOP No. : ___________
- Password control for access.
- Training:
| Name | Training Status | Training Report Availability | Checked by |
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Precaution:
Safety aspect taken into consideration during safety aspect operation of the equipment and process of the product . Checked By: _____________________
X: Validation Procedure :
Carryout the validation exercise as per the validation protocol
| Product : | |
| Batch Number : | |
| Date of Validation : |
XI: Non Compliance:
Details of deviations:
| Deviation Report No. / dated | Checked by |
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Details of OOS results:
| OOS Report No. / dated | Checked by |
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XII: Type of validation:
Concurrent Validation:
XIII: Frequency:
One Validation exercise per year.
XIV: Results/Acceptance Criteria :
| Sr. No. |
Checks |
Acceptance Criteria | Observations |
| 1. | Password verification for editing product :
Enter incorrect password for editing the set product parameters |
System should not accept the incorrect password. | |
| 2. | Access code verification for Adjustment Menu :
Enter incorrect access code to enter into adjustment menu. |
System should not accept the incorrect password. | |
| 3. | Access code verification to advanced configuration option :
Enter incorrect access code to enter into configuration option |
System should not accept the incorrect password. | |
| 4. | Add one additional bar on the carton flap. Ensure that the additional bar is applied using a black coloured permanent marker pen correspond with the dimensions and position specified in the Pharma code guide. This particular carton should be clearly marked as unusable with cross line . For security purpose, the progress of the marked carton through the machine should be monitored. (Note: Same test to be carried out at initial and end of the batch ) | The marked carton is recognized as ‘Error’ and machine must stop. |
XV: Summary of findings of experiment (inference) :
XVI: Recommendation (Including requirements of any additional documentation):
XVII: Team approval :
__________ ___________________ _________________
Production Engineering Quality Assurance
Date : Date : Date :
XVIII: Review (inclusive of follow up action, if any) :
XIX) Approved by :
_________________________ __________________
Plant Quality Assurance GM-Operation
Date: Date:
