1.1 To lay down a standard procedure for instrument malfunctioning and maintenance.
2.0 SCOPE
2.1 This SOP shall be applicable to all the instruments used in the Department of Quality Assurance (QAD).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Maintenance department
4.0 DEFINITIONS
4.1 All equipment used to conduct Good Laboratory Practices shall:
4.1.1 Be properly designed and suited for its purpose
4.1.2 Be calibrated to known standards
4.1.3 Have updated calibration, maintenance, and repair records that are available at study sites and retained in the archives
4.1.4 Have written Standard Operating Procedures (SOPs)
5.0 PROCEDURE
5.1 Maintenance will be performed according to a regular, predetermined schedule, based on manufacturer’s recommendations (as available and relevant), historical observations of problems, operating experience, and how often the instrument is used as per schedule listed according to Format No.: F…………………….
5.2 The department head or designee will ensure that a record of instruments of the Department of Quality Assurance and Animal House Facility that require maintenance is maintained as per Format No.: F ……………… titled as Instrument preventive maintenance log.
5.3 When an instrument fails to meet the performance characteristics established or produces suspect results, the instrument will be labeled as “out of order” as per Format No.:-F………………………. and prevented for use until corrective maintenance is performed.
5.4 Only when it is shown by calibration or a performance check to operate correctly, the instrument be returned to service. Any corrective maintenance will be documented in the maintenance records as per Format No.:-F…………………………...
5.5 Equipment that has been subjected to mishandling, gives suspect results or has been shown to be defective or outside specified limits shall be taken out of service. It will be isolated to prevent its use or clearly labeled as being” out of service”.
5.6 The equipment will remain in this state until necessary repairs have been made and shown by calibration or test to perform correctly.
5.7 Any equipment that is required to be sent off-site for repairs will be properly packaged according to the requests of the vendor conducting the repairs or according to the manufacturer’s instructions.
5.8 The equipment that fails calibration or test to perform correctly even after necessary repairs, it will removed from use and update the Annexures of respective department of SOP……………….. and Format No.:-F……………………...
6.0 ENCLOSURES
6.1 Formats
4.1.2 Be calibrated to known standards
4.1.3 Have updated calibration, maintenance, and repair records that are available at study sites and retained in the archives
4.1.4 Have written Standard Operating Procedures (SOPs)
5.0 PROCEDURE
5.1 Maintenance will be performed according to a regular, predetermined schedule, based on manufacturer’s recommendations (as available and relevant), historical observations of problems, operating experience, and how often the instrument is used as per schedule listed according to Format No.: F…………………….
5.2 The department head or designee will ensure that a record of instruments of the Department of Quality Assurance and Animal House Facility that require maintenance is maintained as per Format No.: F ……………… titled as Instrument preventive maintenance log.
5.3 When an instrument fails to meet the performance characteristics established or produces suspect results, the instrument will be labeled as “out of order” as per Format No.:-F………………………. and prevented for use until corrective maintenance is performed.
5.4 Only when it is shown by calibration or a performance check to operate correctly, the instrument be returned to service. Any corrective maintenance will be documented in the maintenance records as per Format No.:-F…………………………...
5.5 Equipment that has been subjected to mishandling, gives suspect results or has been shown to be defective or outside specified limits shall be taken out of service. It will be isolated to prevent its use or clearly labeled as being” out of service”.
5.6 The equipment will remain in this state until necessary repairs have been made and shown by calibration or test to perform correctly.
5.7 Any equipment that is required to be sent off-site for repairs will be properly packaged according to the requests of the vendor conducting the repairs or according to the manufacturer’s instructions.
5.8 The equipment that fails calibration or test to perform correctly even after necessary repairs, it will removed from use and update the Annexures of respective department of SOP……………….. and Format No.:-F……………………...
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1.
|
List of
instruments requiring preventive maintenance
|
F……………………. |
02 |
|
2.
|
Instrument preventive maintenance (PM) log |
F…………………… |
01 |
|
3.
|
Instrument corrective maintenance (CM) log |
F…………………… |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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