1. PURPOSE
To describe the procedure. Preparation, Review, and Approval of Standard Operating Procedures.
2. SCOPE
This SOP describes the basic principles, defines the responsibilities, and lay down the procedure for preparing SOPs.This SOP shall be applicable to all the SOPs.
3. RESPONSIBILITY
The Quality Manager is responsible for preparing and implementing this procedure.
4. PROCEDURE
4.1 Prepare all SOPs as per the prescribed SOP format.
4.2 Each page including attachment shall consist of a Header, Content, and Footer
4.3 SOPs should be clear, unambiguous, language, easy to understand, practicable, and easy to follow.
4.4 Write the SOPs under the following Sub Headings.
4.4.1 PURPOSE- This section shall describe the justification for the preparation of the SOP and what is expected from it.
4.4.2 SCOPE-This section shall indicate the applicability of the SOP for its intended use.
4.4.3 RESPONSIBILITY-This section shall indicate the responsibilities of the personnel for the intended activity.
4.4.4 PROCEDURE- Write the procedure /method in short sentences. Mention the check to be carried out, records to be maintained, frequency of various operations, check, and special precautions, if any. Enclose all the Attachments with SOP where applicable.
4.4.5 REFERENCES- Mention a list of references or any other guidance document based on which the SOP has been prepared.
4.4.6 REVISION /CHANGE HISTORY - Mention a list of revision/change history based on which the SOP has been prepared
4.4.7 RECORD- Mention a list of references or any other guidance document based on which the SOP has been prepared
4.4.8 ATTACHMENTS- Mention a list of references or any other guidance document based on which the SOP has been prepared
4.5 SOP end with the quote “END OF DOCUMENT”.
4.6 Generation of New SOPs and their control
4.5.1 Department shall prepare the draft SOP as per the procedure.
4.5.2 Draft copy shall be circulated to the responsible persons for its review.
4.5.3 As per the recommendation of the responsible person, the department will make corrections
4.5.4 After approval, a master copy is retained by the quality manager and a controlled copy shall be issued to the user department.
5. REFERENCES: Write if references are available or write NA.
6. REVISION/CHANGE HISTORY: Write change when SOP is revised or write NA.
7. RECORD: Write about the record or table format in the attachment or write NA.
8. ATTACHMENTS: Write YES or NO.
END OF DOCUMENT
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6. List of All SOPs and Documents for the Animal House Facility
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