Verification protocol for Count Verification machine
This article contains information about Performance Verification protocol for Count Verification machine
Performance Verification protocol for Count Verification machine
Objective:
To validate the number of Tablets/Capsules filled in the containers should be accurate, as per display shown in the Tablet/Capsule Counting machine.
Scope:
Applicable for counting the Tablets/Capsules filled in the container.
Justification for selection of item / equipment/ process/ product /system.
Justification for selection of item / equipment/ process/ product /system should be record in validation report.
Site of the study:
Packing Department.
Responsibility:
Packing :
Engineering :
Quality Assurance :
Standard Operating Procedure (SOP) to be followed:
SOP for operating of count verification machine. Reference SOP No. to be recorded in the validation report.
Requirements:
Use hand gloves during Validation study.
Requirement for validation to be recorded in validation report.
Calibration:
Calibration details to be recorded in validation report.
Training:
Training details of personnel involved in exercise is to be recorded
in the validation report.
Precautions:
Ensure proper safety aspects are followed.
Acceptance Criteria of Performance Verification of Count Verification machine :
- The number of Tablets/Capsules counted should be equal to the number of Tablets/Capsules filled in the container on counting machine at initial, middle and end.
- Count verification display screen should show the exact number of Tablets/Capsules.
- The product should not get damaged.
Validation Procedure for Performance Verification of Count Verification machine :
Validation to be carried out for different fill value i.e. 30’s, 60’s. 100’s, (As applicable)
- Load the Tablets/Capsules in machine hopper.
- Set the fill value as applicable in Tablet/Capsule counting machine at initial, middle & end period of the batch run.
- Start the machine, fill the container and collect 10 filled containers from both head (each head 5 containers) .
- Set the count verification machine and then check the fill value of each container by checking count verification display screen and record the observation in validation report.
Note: If the activity is less than one hour then validation should be done at initial and end period of the batch run.
Details of Non-Compliance: (Deviation / Out Of Specification)
Details of Deviations (including justification of acceptance) done to successfully carry out the validation exercise and Out of Specification results obtained should be checked (attach the details in the validation report).
Type of validation:
Concurrent Validation
Frequency:
- New Equipment: First three batches.
- Revalidation: One validation exercise every three years.
Results / Observations:
During the study observation and results should be recorded in the
validation report.
Summary of the validation / study:(inference)
Summarize the findings of the validation study to draw an inference.
Recommendations:
Record the recommendations based on the interpretation of the results In the validation report.
Team Approval:
The individuals who have performed the validation study, supervised the validation, completed the records should approve the validation report.
Review:
The Unit Quality Assurance and Unit Head should review the validation Report. The report should include any follow-up action if required.
Approved by:
Unit Quality Assurance and Unit Head should finally approve the validation report.
Attachments:
Annexure (if any) to be attached with validation report should be recorded.
Abbreviations:
SOP : Standard Operating Procedure
OOS : Out Of Specification
Sr. : Serial
No. : Number
