1.0 OBJECTIVE
1.1 To lay down the procedure for identification and control of deviations.
2.0 SCOPE
2.1 This SOP shall be applicable to all departmental activities that may or may not affect the final quality characteristics of testing in the Department of Quality assurance (QAD) and Animal House Facility (AHF).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Head- AHF
4.0 DEFINITIONS
4.1 Deviation: Deviations shall be defined as: “Any departure from the procedures described in any approved SOPs/ Specifications/ General Test Procedure & Standard Test Procedures”.
5.0 PROCEDURE
5.1 Deviations may arise due to any of the following causes:
5.2 Human Error, Equipment and utilities failures/ breakdowns/ malfunctioning, Power supply failures/ interruptions, Breakdown in support services/ utilities, deviations from documentation procédures, Analytical Deviations, Unexpected utility breakdown during testing.
5.3 Any deviation from standard procedures will be initiated by the concerned person, who is directly involved with the activity in the prescribed format as per Format No. F……………....
5.4 The deviations shall be reviewed and approved by the head - QA with respect to established procedures, regulatory commitments, historical data, and GLP.
5.5 In case of unplanned deviations, the reasons for the same shall be clearly identified and a corrective action proposed.
5.6 Deviations shall be serially numbered and the QA department shall maintain the record for the same as format F…………….
5.7 Numbering of Deviation
5.7.1 The Quality Assurance department will assign the deviation number as per unique numbering system of 13 characters in the following manner: DV/XXX/YY/ZZZ
Where 1st and 2nd characters are ‘DV’ which signify Deviation, 4th, 5th and 6th characters are ‘XXX’ which signify ‘Department Code’ to which logbook belongs i.e. QAD for Quality Assurance, AHF for Animal House Facility; Character no. 8th and 9th are ‘YY’ which signify the last two digits of the year in which the Deviation is filed; The 11th, 12th and 13th characters ‘001’ signifies the Sr. No. of Deviation; Character No. 3rd, 7th and 10th are oblique marks ‘/’.
5.7.2 For example The numbering of the Deviation of AHF Department for the year 2015 shall be DV/AHF/15/001
5.8 Monitor the corrective and preventive action given in the deviation form.
5.9 Close the deviation as format F……………..
5.10 For the closing of the deviation, QA shall recommend for proposed corrective actions and after reviewing of supporting data QA shall close the deviation with justification as well QA shall recommend for change control (if required).
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1. |
GLP Deviation reporting form |
F…………………… |
03 |
|
2. |
Deviation Record 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 THE DOCUMENT
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