Objective for PQ of Hardness Tester
To carry out the PQ of Hardness Tester as per approved, OQ in company..
The scope of this document is to confirm that the design, implementation and operation of the Hardness Tester, meet its design intention, specifications and operational requirements. This document details the dynamic attributes of the instrument, and provides evidences of Hardness Tester, is operated as per the specification.
TABLE OF CONTENT
| Particulars | Page No. |
| Title page | |
| Table of contents | |
| Objective | |
| Project background & system description | |
| Test assumption and limitations | |
| Validation team and responsibility | |
| Pre-approval of documents | |
| Validation strategy | |
| Qualification procedure | |
| References | |
| Acceptance criteria | |
| Result | |
| Deviation | |
| Summary | |
| Conclusion | |
| Recommendations | |
| Attachments | |
| Post-approval of documents |
TEST ASSUMPTION & LIMITATION
- Calibration standard should be required during the calibration of instrument.
- Suitable hardness method should be required for particular test because results may be different in multiple methods.
- Test surface should be cleaned because the surface finish of the test surface affects the result of the hardness test.
VALIDATION TEAM AND RESPONSIBILITY
| Department | Responsibility |
| Quality Assurance | Preparation of protocol and compilation of report.Review, approval and certification of the protocol/ reports. Execution & approval of qualification activities as per the protocol & certification after successful qualification of instrument. |
| Production | Review of protocol and report.Execution of qualification activities as per the protocolResponsible for the compliance of qualification data |
| Quality Control | Review of protocol and report.Responsible for analysis of samples & evaluations of the test results. |
| Engineering | Review of protocol and report.Execution of Qualification activities with the user/ concern department as per the protocol. |
Also Check : PQ of Disintegration Test Apparatus
PRE APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer QA |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
VALIDATION STRATEGY
Brief Process Description:
Tablet hardness testing is a technique used by the pharmaceutical industry to determine the breaking point and structural integrity of a tablet and find out how it changes “under conditions of storage, transportation, packaging and handling before usage” The breaking point of a tablet is based on its shape.
Validation or qualification strategy shall remains as per SOP. After successfully execution/verification of the DQ, IQ, OQ documents, PQ shall be initiated as per the approved PQ protocol. Before execution of PQ, SOP of the concerned instrument should made effective. After successful PQ, instrument can be used further in manufacturing.
PQ of Hardness Tester PROCEDURE
PQ includes the verification and documentation of instrument performance. It verifies that instrument is working within the accepted range and performs as expected in real-world conditions. PQ focuses on the manufacturing process, with the system testing done at operational capacity.
- The Performance Qualification status of the instrument shall be checked and the execution shall only be started only after complete execution/verification of operational qualification report.
- The power supply and connected utility shall be checked before starting performance qualification.
- The operating functions of control panel switches and buttons shall be checked.
- Availability of product that shall be used to check the performance of the instrument.
Performance Verification
Objective of this performance verification is to provide documented evidence that instrument perform as per respective and up to its operating & performance range.
Standard Operating Parameters Verification
Objective of this verification is to provide documented evidence that instrument perform satisfactory as per its standard operating procedure.
Prerequisites
Before executing the performance qualification the following requisites shall be ensured.
| Prerequisites | Available/Not available |
| Availability of the PQ protocol | |
| Availability of OQ protocol & report | |
| Standard Operating Procedure for Instrument |
Cleaning check:
| Check points | Observation | Checked By (Sign & Date) |
| Check the cleanliness of the instrument. | ||
| Check the cleanliness of the internal & external surface of the instrument. |
Safety precaution while operating of Hardness Tester:-
Mask and gloves shall be wear during operation.
Do not touch the jaws while operating.
Performance check of the machine/instrument:-
| Test | Acceptance Criteria | Observations | Done By Sign/Date | Checked By Sign/Date |
| Check the instrument or proper placement. | Instrument should be place in adequate space & there should be enough space | |||
| Check the instrument or abnormal noise/ vibration. | There should not be any abnormal noise/vibration | |||
| Switch on the instrument. | When powered on, instrument should initialize & display show 0.00. | |||
| Check the functioning of unit key. | After pressing the unit key, it should show the units Kp, N, lb, Kg/cm2 |
| Standard Weights in Kg | Actual value | Observed value | Inference | Acceptance ±2.0% of Actual value |
| 2 Kg | ||||
| 5 Kg | ||||
| 10 Kg |
Comparative study between hardness testers
| Standard Parameter | Hardness value from Other Model | Hardness values from Other Model | Difference |
| NLT 3.0 kg/cm2 | |||
Instrument shall be operating as per the standard operating procedure for operation and cleaning of Hardness Tester SOP.
Record the details of the batch passed through the Hardness Tester.
| Product Name | Batch Number | Observation | Checked By | Reviewed By |
REFERENCES:
Instrument Qualification & Re-qualification, DQ, IQ & OQ of hardness tester.
ACCEPTANCE CRITERIA:
Instrument should be operating as defined in the standard operating procedure, if differ then record deviation & check the performance of instrument.
Instrument should properly perform as per the standard requirements.
Operation shall be smooth and there should not be any abnormal sound/ noise
RESULT:
____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Checked By (Sign & date):________________
DEVIATION
| Deviation |
Comment: ________________________________________________________________________
Checked By (Sign & date):________________
SUMMARY:
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Checked By (Sign & date):_______________
CONCLUSION:
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Checked By (Sign & date):________________
RECOMMENDATIONS
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Checked By (Sign & date):________________
ATTACHMENTS:
| Document name | Reference No. | Checked by Sign & Date |
POST APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer QA |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production | |||
| Head Quality Control |
Approved by
| Designation | Name | Date | Signature |
| Head QA |