Verification protocol for Pharma code system

This article contains about Performance Verification protocol for Pharma code system.

Performance Verification protocol for Pharma code system

Objective:

To validate the Pharma code checking system by verifying that the component ( or ) system will function accordingly to the system specification.

Scope:

Applicable to Pharma Code checking.

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.

Justification for selection of item / process / product (formula) /storage condition:

 Justification for selection should be recorded in the report.

 Site of Study:

Pharma  Packing

Responsibility:

Representative  from

Production

Quality Assurance

Engineering

Description of the Equipment to be used:

Equipment : Cartonator  ·

CODE No :  Details to be recorded in the report.

• Date of Equipment Qualification done is to be recorded in the report.

Equipment : Pharma coding system ·

CODE No :  Details to be recorded in the report.

• Date of Equipment Qualification done is to be recorded in the report.

Standard Operating Procedure (SOP) to be followed:

SOP for operating  cartonator :

Reference SOP Number to be recorded in the report.

SOP for operating Pharma Code reader :

Reference SOP Number to be recorded in the report.

Control:

Requirements:

 SOP for operating Cartonator and Pharmacode to be followed

Password control for access.

Training :

  Trained personnel details to be recorded in the report.

Calibration :

 Calibration details to be recorded in the report (if any)

Precautions :

 Safety aspects during operation of the equipment and processing of the

product must be ensured.

Validation Procedure for Performance verification of Pharma code system :

• Operate the Cartonator & Pharma code system as per SOP.
• Challenge the following for proper functioning :

Sr. No.	Checks	Acceptance Criteria
1.	Password verification  for editing product : Enter incorrect password for editing the set product parameters Record the observation in the report.	System should not accept the incorrect password.
2.	Enter correct pass word for editing. Record the observation in the report.	System should go to edit mode.
3.	Add one additiona 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. 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 should be done at initial and end of the batch)	The marked carton is recognized as ‘Error’ and machine should stop automatically.

Acceptance criteria of Performance verification of Pharma code system :

Refer above point

 Non Compliance:

Details of deviations (including justification of acceptance) done to successfully carry out the validation exercise and any OOS results obtained should be checked. ( Attach the details in the Validation report)

 Type of validation:

 Concurrent Validation

 Frequency of Performance verification of Pharma code system :

One Validation exercise per year.

Results for Performance verification of Pharma code system :

 Record the observations during the study and results obtained from Validation Report.

 Summary of findings of experiment (inference):

Summarize the findings of the Validation Study to draw an inference.

 Recommendation (Including requirements of any additional documentation):

Record the recommendations based on the interpretation of the results of the Validation Report.

Team approval :

 The individuals who have performed the Validation Study, supervised the validation, completed the records, performed the testing of the

product should approve the validation report.

Review (inclusive of follow up action, if any) :

 The Validation Report should be reviewed by plant Quality Assurance

and plant Head. The report should include any follow up action if

required.

Approved by :

 Validation Report should be finally approved by plant Quality Assurance

and plant Head.

Annexures:

Annexures (if any) attached to the Validation Report should be recorded.

 Abbreviations:

OOS             :   Out of specification

SOP              :   Standard Operating Procedure