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 |