Verification Report for Count Verification machine

This article contains information about Performance Verification Report for Count Verification machine

Performance Verification Report for Count Verification machine

Objective:

 To validate the number of Tablets/Capsules filled in the containers should be accurate, as per display shown on Tablet/Capsule counting machine.

Scope:

 Applicable for counting the Tablets / Capsules filled in the container.

Justification for selection of item / equipment / process / product /system :

 

Site of the Study:

 Packing Department

Location : ___________

Responsibility:

Packing                                    : ___________________

Engineering                              : ___________________

Quality Assurance                    : ___________________

Standard Operating Procedure (SOP) to be followed :

 SOP for operating of count verification machine.

SOP No.: _________

Requirements for Verification Report for Count Verification machine :

Calibration:

Sr. No.	Code No.	Calibration Done on	Calibration Due on

Training:

Sr. No.	Name of Persons	Training Status	Availability of Report	Checked By

Precautions while Verification Report for Count Verification machine:

Acceptance Criteria:

• 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:

 Carry out the experiment as per Validation protocol  :

Product Name
B. No. / Export -Order No.
Date of Validation

Observations : At Initial

 Container fill Value : ________ Tablets/Capsules      Container Code : _____________

Sampled Time : ____________                                    Checked by/date : _____________       

Sr. No.	Fill Value (in Nos.)		No. of Tablets/Capsules display on the screen	Checked by/date
	A	B

Observation : At middle

Container fill Value : ________ Tablets/Capsules      Container Code : _____________

Sampled Time : ____________                                    Checked by/date : _____________       

Sr. No.	Fill Value (in Nos.)		No. of Tablets/Capsules display on the screen	Checked by/date
	A	B

Observation : At end

Container fill Value : ________ Tablets/Capsules      Container Code : _____________

Sampled Time : ____________                                    Checked by/date : _____________       

Sr. No.	Fill Value (in Nos.)		No. of Tablets/Capsules display on the screen	Checked by/date.
	A	B

Details of Non-Compliance: (Deviation / Out Of Specification) :

 Details of Deviation (If any):

Deviation Report Number	Deviation Report Dated	Checked by/date

Details of Out of Specification (If any):

OOS Report Number	OOS Report Dated	Checked by/date

Reviewer Comments/remark:

Type of Validation:

Concurrent Validation

Frequency for Verification Report for Count Verification Machine:

1. New Equipment: First three batches.
2. Revalidation: One validation exercises every three years.

Results / Observations:

 

Summary of the validation / study:(inference)

 

Recommendations:

 

Team Approval:

 

 

_________                    ____________                  _______________

Packing                          Engineering                     Quality Assurance

Date:                              Date:                               Date:

 

Review (Including follow up action, if any):

 

Approved by:

 

__________________                                             ________________

Plant Quality Assurance                                                GM Operation

Date:                                                                           Date:

 

Attachments:

 

Abbreviations:

SOP           :         Standard Operating Procedure

OOS          :         Out Of Specification

Sr.             :         Serial

No.            :         Number