Generation of a new SOP by changing the previous SOPs

1.0 OBJECTIVE:

To lay down the procedure for generation of a new SOP upon changing the previous SOP due to some reason.

2.0 SCOPE:

This shall be applicable to all the SOPs.

3.0 RESPONSIBILITY:

3.1 Executive/ Officer Q.A/ Designee: Preparation and Revision/ Periodic review of SOPs.

3.2 Q.A Head/ Designee: Review and Training of SOP.

3.3 Site Quality Head/ G.M-works/ Designee: Approval of SOP.

4.0 ACCOUNTABILITY:

4.1 Head of the Q.A Department.

5.0 PROCEDURE:

5.1 User dept. shall prepare the draft SOP as per the SOP on SOP in a Pharmaceutical Industry. Draft copy shall be identified by stamping or watermark on each page.

5.2 Draft copy shall be circulated to the responsible persons for its review. The responsible persons may recommend for any changes in the text.

5.3 Based on the recommendation, user dept. shall correct the draft SOP and take final print out for approval and authorization along with Change History Log.

5.4 After approval and authorization, user dept. shall submit the Original Copy (Master Copy) of SOP along with ‘Change History Log’ to Q.A for control and issuance and shall destroy the draft SOP.

6.0 REVISION LOG:

Revision No.	Effective Date	Reason
00		New SOP

7.0 REFERENCES:

7.1 Not Applicable.

8.0 ANNEXURES:

8.1 Not Applicable.

9.0 ABBREVIATIONS:

Abbreviation	Expanded Form
SOP	Standard operating procedure
&	And
No.	Number
Ltd.	Limited
Q.A	Quality Assurance
G.M	General Manager
QA	Quality assurance
F	Format