STANDARD OPERATING PROCEDURE FOR SOP

1.0 PURPOSE :
To provide a procedure for preparing a Standard Operating Procedure.
2.0 SCOPE :
Applicable to all operations and activities on site. Carried out in Production, Stores, Quality Control, Engineering, Quality Assurance & Research and development
3.0 RESPONSIBILITIES :
Chemists, Officers and Managers of the respective departments.
4.0 PROCEDURE :
4.1 Standard Operating Procedure is written down authorised document that in details different general procedures, equipment operation, equipment cleaning, equipment maintenance, Stores procedures, Quality control procedures, Quality assurance procedures,R&D Procedures and responsibilities of key person at different levels of the organisation. SOP is an instruction that establishes-in writing-who is to do, what to do, and when to do.
4.2 Quality of SOP :
4.2.1 SOP should be in detail.
4.2.2 Should give details step wise.
4.2.3 Should be free of ambiguity.
4.2.4 Should be simple, easy and universally understood.
4.2.5 Should be comprehensive yet exact.
4.2.6 Should give complete and actual information
4.2.7 Should be current and easy to implement.
4.3 Preparing a new SOP
4.3.1 The purpose of writing down the SOP should be mentioned under the heading PURPOSE.
4.3.2 The Procedures / activities to which the SOP is applicable should be mentioned under the heading SCOPE.
4.3.3 The department, which are involved in the particular operation / activity should be mentioned under the heading RESPONSIBILITY.
4.3.4 The detailed procedure should be written down under the heading PROCEDURE.
4.3.5 The procedure should be written down either by chemist or officer/executive stepwise of the user department, in consultation with the person who is involved in the particular operation.
4.3.6 The procedure should be written down point wise which are numbered.
Eg. :
a) If PROCEDURE is numbered as 4.0, then the points should be Numbered as 4.1, 4.2..., etc.,
b) If under number 4.1, further points are to be detailed ,they should be numbered as 4.1.1, 4.1.2 ...., etc.,
4.3.7 The written down procedure should be checked against the actual operations by the department head.
4.3.8 The responsible person will check and allot the SOP No. by checking the Master List of SOP.
4.3.9 The standard operating procedure is typed with the following details
4.3.9.1 Title of the SOP on each page
4.3.9.2 Date of Issue
On each page
(Month and year)
4.3.9.3
Supercedes Doc. No. and Date
on each page (Nil)
4.3.9.4
SOP No. and version
On each page
No. as per following
SOP subject
SOP No.
Tablets
General procedures:
T/GN/ SOP No./1.0
Equipment Operation:
T/EO/ SOP No. /1.0
Equipment Cleaning:
T/EC/ SOP No. /1.0
Liquids
General procedures:
L/GN/ SOP No./1.0
Equipment Operation:
L/EO/ SOP No. /1.0
Equipment Cleaning:
L/EC/ SOP No. /1.0
Dry syrup
General procedures:
D/GN/ SOP No./1.0
Equipment Operation:
D/EO/ SOP No. /1.0
Equipment Cleaning:
D/EC/ SOP No. /1.0
Planned Preventive maintenance
Tablets :
T/PPM/ SOP No./1.0
Liquids
L/PPM/ SOP No. /1.0
Dry syrup:
DS/PPM/ SOP No. /1.0
Factory General :
F/GN/SOP No/1.0
General Procedures:
PR/S.O.P.No./1.0
UTILITIES
General Procedures:
UT/GN/S.O.P.No./1.0
QUALITY CONTROL
General Procedures:
QC/GN/S.O.P.No./1.0
Instrument Operation:
QC/IO/Operation No./1.0
Instrument calibration
QC/CL/Calibration No./1.0
Microbiology Procedure:
QC/MB/S.O.P.No./1.0
STORES
General Procedures:
ST/GN/S.O.P.No./1.0
4.3.9.6 Page No.:
on each page (1 of 5, 2 of 5 …… 5 of 5)
4.3.9.7 Purpose
4.3.9.8 Scope
4.3.9.9 Responsibility
4.3.9.10 Procedure
4.3.9.11 Annexures (if any)
4.3.9.12 Prepared by; Checked by and Authorised by - on each page
4.3.10 The copy is checked for any errors and corrected.
4.3.11 The corrected copy is then signed and dated by:
4.3.11.1 General, Equipment Operation, Equipment Cleaning (Tablet) :
Prepared by ­- Production Chemist / Production Officer
Checked by - Deputy Manager Production
Authorised by – Manager Quality Assurance
General, Equipment Operation, Equipment Cleaning (Liquids) :
4.3.11.2
Prepared by ­- Production Chemist / Production Officer
Checked by - Production Manager
Authorised by - Manager Quality Assurance
4.3.11.3
Utility SOP:
Prepared by ­- Officer Maintenance
Checked by - Manager Maintenance
Authorised by - Manager Quality Assurance
4.3.11.4
Planned Preventive Maintainence
Prepared by - Officer Maintenance
Checked by - Manager Engineering Services
Approved by - General Manager Engineering
Authorised by - Manager Quality Assurance
4.3.11.5
Quality Control S.O.P.
Prepared By - Q.C Officer / Asst. Manager- Q.C
Checked By - Quality Control Manager
Authorised By - Quality Assurance Manager
4.3.11.6
All the SOP which are classified under Company policies should be signed by the
Prepared by ­-
Checked by -
Authorised by –
4.3.12
The signed copy shall be stamped as “MASTER COPY” (in Blue) on to the back (non-text) side of the page and filed in the Master Copy File. The master list should be updated immediately.
4.3.13
A photocopy of the document is issued to the respective department by stamping it as “CONTROLLED COPY” (in Green) on the right top corner of each page on text side and initialed by Q.A Personnel, who issues the copy as per the document control system. Copies which are issued for reference, shall be stamped on each page as
“unCONTROLLED COPY”(in Black) on the text side.
4.3.14
Document required for display, shall be stamped as “DISPLAY COPY” (in Blue) on the right top corner (text side) of each page, initialed by Q.A Personnel who issues the copy; inserted in a docket and displayed at the relevant place.
4.3.15
Stamps used by the department should tally the specimen attached.
ANNEXURE I
MASTER COPY
BLUE COLOUR
CONTROLLED COPY
GREEN COLOUR
DISPLAY COPY
BLUE COLOUR
OBSOLETE COPY
RED COLOUR
UNCONTROLLED COPY
BLACK COLOUR
4.3.16
All SOP should be reviewed once in TWO Years
4.4
Incorporating changes in the existing SOP
4.4.2
When any changes are made in the relevant procedure/activity, the existing SOP should be changed immediately.
4.4.3
Fill in the Change Control Form mentioning the changes to be made in the document and get it authorised by Q.A Manager.
4.4.4
The version number of the SOP should be changed / updated
e.g. If the existing document has a version number of 1.0, the subsequent change in the document should have a version number of 1.1
4.4.5
A review sheet has to be attached to the revised SOP, detailing the changes made in the SOP.(Anexxure – II)
4.5
RETREIVAL OF SUPERCEDED SOPs
4.5.1
Prior to issuing the revised copy of the SOP to concerned departments, the superceded copy will be retrieved from the respective departments and will be destroyed. The record for issue, retrieval and the destruction of superceded SOPs will be maintained.
4.5.2
The master copy of the superceded SOP will be stamped as “OBSOLETE COPY” (in Red) ink on the top right corner (text side) of each page and will be filed by QA for future reference.