SOP PREPARATION AND FORMAT DESIGNING
RESPONSIBILITY: It shall specify the person responsible for carrying out and monitoring the activity as per the SOP.
PROCEDURE: It shall give all steps required by the process in a proper sequence and instructions to be followed while carrying out the activity so as to achieve the desired goals.
Procedure shall be:
a) Logically lay out.
b) Written in the imperative (authoritative) tense.
c) User friendly.
d) Simple to understand and in plain unambiguous English.
e) To the point with no unnecessary information.
f) In standardized terminology.
ABBREVIATION:This shall include list of abbreviations used and their meaning.
ANNEXURE:This shall include list of annexure attached.
REFERENCE:This shall include list of reference documents.
HOD : Head of the Department
SOP : Standard Operating Procedure.
QA : Quality Assurance
DGM : Deputy General Manager
Annexure – SOP/QA/002/1 - ‘Standard Operating Procedure’ Form.
SOP issuance logbook
Standard SOP format.
GENERAL NOTES FOR SOP DRAFTING
1. All SOPs should be made in Approved format only.
2. There shall be written down procedure SOP for each activity.
3. The need of SOP’s for various equipment / operation shall be consultation with Department Head along with actual user.
4. SOPs for machine operation shall be prepared by in consultation with engineering department and user department.
5. SOPs for validation, stability study and calibration shall be prepared in consultation with Quality Assurance.
6. SOPs shall be prepared in language that is easy to understand.
7. The writing of procedure in an SOP is based on the category of SOP. Specialized SOPs: Standard Operating Procedure of this category includes following points:
General conditions or prerequisites
8. Control of Soft Copy of SOP
- Soft copies of SOP control though Password Protection on Compact Disk with Corporate QA only. The access shall be restricted to QA Officer or Authorized personnel of QA.
Soft copy will be stored in separate folder as :
Main Folder as SOP
Sub Folder as Department code e.g. MN, ST, QA, QC etc.
Files as ANK/PRSOP/001,ANK/PR SOP/002, ….etc. for each department.
9. Control of Master Copy of SOP:
- Hard copy of SOPs shall be stored in QA department. The hard Master Copy will bear original signature and red stamped of “MASTER COPY” at bottom right side corner of the each page.
10. Control of Controlled Copy of SOP:
- Controlled copy is a photocopy of Master Copy and is under the control of QA for issue to user department which is stamped as “CONTROLLED COPY” at blue space at bottom side of each page in blue ink. Copying of this copy is strictly prohibited. The stamp shall be applied in blue ink on each page and shall bear the original signature and date issue of QA personnel with black ink.
11. Issuance of SOP:
- Controlled copy of SOP shall be issued to the user department, each SOPs issued and entry is recorded in SOP issue register.
- Recall of SOP:SOP can be recalled in following condition:
- SOP is not displayable /distorted
- SOP is not legible
- For review
- Record of recall shall be maintained.
Review of SOP: SOP shall be reviewed after every 2 years from the date of preparation or when any change to be made in the procedure, format etc. through change control system. Only two reviews can be done and same will be re-printed, if there is no change in the content of SOP.
12. Destruction of SOP:
- Master copy of obsolete SOP shall be stamped as OBSOLETE in Red Ink and preserved for one year from the date of absolution. The destruction shall be carried out by QA personnel and recorded with date of destruction. Obsolete controlled copy will be recalled and destroyed by shredding.
13. Copies to Distribution Sites:
- Quality Assurance
- Quality Control
- Personnel & Administration
14. Review History:
3. Pharmaceutical Quality Assurance, M.A. Potdar, Nirali Prakashan, Pune.
4. Current Good Manufacturing Practices, M.A. Potdar, Pharma-Med Press, Hyderabad.
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