Re-qualification Of Equipment's

Every equipment and Machinery in the Plant undergoes the Requalification. :

                       Equipment requalification should be done as per the validation master plan.

1.1.1        Requalification: The act of reconfirming that a validated system or piece of equipment remains capable of achieving the intended results within planned regular intervals.

1.1.2        Equipment Requalification: The act of planning, carrying out and recording the results of tests on equipment to confirm its capabilities and to demonstrate that it will perform as intended.

1.1.3        Equipment Requalification Protocol: A written plan stating Requalification will be conducted, including test parameters, equipment characteristics, and decision points on what constitutes acceptable test results shall be prepared.

                                    Report of the equipment Requalification shall be recorded in the Requalification report in which the records, results and evaluation of a completed Requalification program shall be assembled. All the details suggested in the protocol shall be recorded.

Requalification protocols are prepared for, equipments defined as critical for the process.

The following sections are to be included in the Requalification protocol:

·           Protocol title: This section should provide the title for the protocol

·            Table of contents

·            Protocol approval (Pre & Post Approval)

·            Objective

·            Reason for requalification

·           Responsibility

·            Methodology

·            Requalification Criteria

·            Deviation report

·            Requalification report

·            certification

The Requalification protocol should provide an index indicating the phase of the program included and documented in it. The scope is to facilitate the location of the information of Requalification.

1.2              Each machine shall be requalified as per the respective Requalification protocol.

1.3              Establish Requalification plan and Requalification protocols for the unit process.

1.4              Nominate a team comprising of User Department, QA and QC, and Engineering members.

1.5              Carry out the Requalification as per the respective Protocol.

1.6              Statistics can be made to interpret data obtained and provide meaningful information during the revalidation/requalification Exercise.

            NOTE:

·         The Requalification protocol and report shall be approved as per SOP. Once all the protocol steps have been completed, all the documentation is to be organized. The data and information obtained must be reviewed and its acceptability against the specified acceptance criteria must be determined. A report detailing the acceptability and any deviations in test procedures, methods, or results must be identified and explained. A final conclusion must be prepared and included as part of the report.

2.0              LIST OF ANNEXURE AND FORMATS:                            

Sr. No.	Title of Protocol	Protocol No.
01	Equipment requalification protocol	AE / RQ - 001