1.0 OBJECTIVE
1.1 To lay down the procedure for the management of changes, which may affect the analytical testing quality directly or indirectly.
2.0 SCOPE
2.1 This SOP shall be applicable to the changes made in any of the following in the Department of Quality Assurance (QAD) and Animal House Facility (AHF).
Ø Standard Operating Procedures
Ø Specifications and Analytical procedures
Ø Documents
Ø Equipment
Ø Facility
Ø Vendor of Raw materials
Ø Others
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Head- AHF
4.0 DEFINITIONS
4.1 Changes are divided into three categories:
4.2 Minor change: These changes are unlikely to have an impact on the quality or process. Attributes of the analytical testing.
4.3 Moderate change: These changes are usually for improvements to the process, analytical testing, and procedures and may not have an adverse effect on the quality of the analytical testing.
4.4 Major Change: These changes are likely to have an impact on the critical attributes of the process, procedure, or analytical testing. These changes are evaluated against the present regulatory commitments and all regulatory requirements are followed.
5.0 PROCEDURE
5.1 Change Control Initiation and Approval
5.1.1 Request for changes is initiated by any authorized personnel involved with the relevant operation, procedure, or equipment. The request for change must be accompanied by a scientific rationale.
5.1.2 The departmental head shall fill the requisition in the format No. F............... to issue the format no. F................ entitled ‘Change Control Assessment Form”.
5.1.3 The initiator shall give the reasons/justification for the proposed change with signature and date. The initiator of the change shall also attach appropriate data or backup documents, drawings in support of the change proposal and forwards them to authorized QA personnel for approval.
5.1.4 Till a change is approved and all conditions accompanying the approval for the change are met and documented, the original status is maintained.
5.1.5 On receipt of the Change Control Assessment Form, QA personnel shall send the same to other departments for their comments.
5.1.6 QA personnel shall evaluate the proposed changes and categorize the same as minor/moderate or major depending upon the impact of changes.
5.1.7 QA personnel shall write comments after assessment of the change control form and if all changes are accepted and approved a change control number shall be assigned to the proposed change.
5.1.8 Records of change control shall be maintained as per format no. F....................
5.2 Numbering of change control
5.2.1 All change control shall be numbered as per a unique numbering system of 13 characters as below:
CC/XXX/YY/ZZZ
Where, 1st and 2nd characters are ‘CC’ signify Change Control; 4th, 5th and 6th Characters are ‘XXX’ which signify ‘Department Code’ to which Change Control belongs i.e. QAD for Quality Assurance Department, AHF for Animal House Facility; 8th and 9th Characters are ‘YY’ signify the last digit of the year. E.g. For 2015 its 15; 11th, 12th and 13th Characters are ‘ZZZ’ which signify the serial number of Change Control.eg. 001, 002, etc.; Character no. 3rd, 7th and 10th is oblique Mark (/).
5.2.2 For example: The first change made in QAD in the year 2021 shall get the change control number CC/QAD/21/001.
5.3 QA person shall approve the change control form and provide recommendations or additional study (Qualification, Validation, Stability etc) to be performed to implement the change. At this stage, QA person shall note down all the related documentation that may get affected due to the proposed change.
5.4 For all changes, which are minor, moderate, and major in nature, authorization by Head - QA shall be required.
5.5The initiator who had initiated the change shall be responsible to communicate the approved and implemented changes to the affected users.
5.6 Head - QA shall ensure that implementation of the change updates in all related/affected documents of the company within 30 days.
5.7 Ensure that before the implementation of change and that all the affected activities/documents are taken care of.
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1. |
Change control Assessment form |
F……………………. |
02 |
|
2. |
Change control Record |
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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