SOP for File Note

1.0 OBJECTIVE
To laid down a procedure for raising file note.

2.0 SCOPE
This procedure is applicable for the changes made having no GMP concern.

3.0 RESPONSIBILITY
3.1 Concerned department Heads to raise/initiate and Implement.

4.0 ACCOUNTABILITY
4.1 Executive Director, Quality

5.0 PRECAUTIONS
5.1 File note reference number should be issued in the log book.
5.2 After approval a issued photocopy of file note should be send to originating department and original copy shall be retained for record.

6.0 PROCEDURE
6.1 Any changes made for the improvement in the set norm shall be brought on the record by the concerned department.
6.2 The changes which are not required to be made through deviations or change control shall be noted in the File note.
6.3 File Note shall be raised by concerned department and approved by Head of Quality.
6.4 Supporting data to justify the changes shall be attached with file note.
6.5 Incidences or any change to the documentation /processes are out of the purview of file note.
6.6 QA shall assign reference number to File Note (Annexure-I) in a log book (Annexure-II) as follows:
Eight characters  – numeric sequential number shall be given to file note.
e.g. T-II/001
Where,
T-II represents for Track–II
/ (slash)
001 represents for numerical serial number of the file note.
6.7 QA shall send the issued photocopy of file note to originating department and original copy shall be retained for record.

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