MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT
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TABLE OF CONTENTS
1.0 Pre-Approval
2.0 Overview
2.1 Purpose
2.2 Responsibility
2.3 Requalification
2.4 System Description
3.0 Performance Qualification Procedure
3.1 Test procedures.
3.2 Deficiency (if any) and corrective Action Report
4.0 Acceptance Criteria
5.0 Remarks (if any)
6.0 Summary
6.1 Conclusion
6.2 Post –Approval
7.0 Appendix
7.1 Abbreviations
7.2 List of documents
1.0 Pre-Approval
- Signing of this Approval page of Performance Qualification Protocol indicates agreement with the Performance Qualification approach described in this document. Should Modifications to the Performance Qualification become necessary; an addendum will be prepared and approved.
2.0 Overview
2.1 Purpose:
The purpose of
this protocol is to provide an outline for the Performance of equipment for
static attributes to verify that:
- Machine is performing as per functional requirement mention in design specifications.
2.2 Responsibility:
The validation group comprising of a
representative from each of the following departments shall be responsible for
the overall compliance with this protocol:
- Project Department
- Engineering Department
- Production Department
- Quality Assurance Department
The Projects and
Engineering Department shall be responsible for checking proper process
validation and recording validation data as per the procedures outlined in this
protocol.
The Quality
Assurance Department shall be responsible for the final review of the
qualification documents and its compliance to meet the acceptance criteria of
the Performance Qualification protocol.
The summary report shall be approved by the head of Project, Engineering, Production and Quality Assurance.
2.3 Requalification:
Performance Qualification to be re-qualified on:
- Replacement of major component of the equipment with a new component.
- Any major modification in the existing equipment.
- Any change in validation parameter.
- Shifting of the equipment from one location to another.
2.4 System Description
- Ribbon Blender is used for mixing dry or dump materials and used for tablet granulation. It consists of a 'U' shaped trough, solid SS end plates, SS shaft with specially designed paddles. The shaft is coupled with heavy duty gear box & motor. The shaft is supported on heavy duty bearing blocks at both the ends and provided with Teflon seals & stuffing box.
- Top cover is provided with SS grill structure for easy visibility during mixing operation. The motor- gear box assembly is completely covered in enclosure on/off push button box is provided with the machine with DOL starter. All SS parts are polished to mirror finish from inside mirror and outside parts are matt finished.
Salient Features
- Standard and GMP model with contact parts in SS 316 quality.
- Top cover with SS lid.
- Solid stainless-steel end covers and frame work on the trough in even standard models for long trouble-free life of the machine.
3.0 Performance Qualification Procedure
3.1 Test procedures.
- Output capacity Test
- Procedure: Make all the initial setting of the machine to get desired capacity
- Acceptance Criteria: Machine should be capable of doing the set parameter
- Output Quality Chart
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Sr. No |
Processed material at regular
interval |
Accepted |
Rejected |
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3.2 Deficiency (if any) and Corrective Action Report
If there is no deficiency, then write N. A.
|
Checked
by (Project) |
Name |
Sign. |
Date |
|
Verified
by (Engineering) |
Name |
Sign. |
Date |
4.0 Acceptance Criteria
Performance
Qualification shall be considered acceptable when all the conditions specified
in various forms under section 3.0 have been met.
Any deviation
from the acceptance criteria of the specific check point shall be reported and
decision should be taken for the rejection, replacement or rectification of the
equipment/component.
5.0 Remarks (if any):
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
6.0 Summary:
|
Checks |
Observations |
Remarks |
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Whether acceptance criteria of the protocol and Specific check points
are met. |
Yes/No
|
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6.1 Conclusion:
|
Mass Mixer bearing Mac No. ------
Is / Is Not qualifying the
performance qualification test as per the guideline described in this
Protocol Can Be / Not Be tested
for its performance qualification. |
6.2 Post-Approval
Signatures
7.0 Appendix
7.1 Abbreviations7.2 List of Documents
1.
M.O.C. of S.S. 316 & 304 Quality
Material
2.
Motor Certificate
3.
Gasket Certificate
4.
G.A. Drawing
.webp)
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