1.0
OBJECTIVE:
To lay down a procedure to write / prepare, review,
approve, authorize, control, revision and destruction of Standard Operating Procedure
(SOP).
2.0
SCOPE:
This procedure is applicable to prepare the Standard Operating Procedure
(SOP) for initiation, implementation, review, approval, authorization,
issuance, control, revision of SOP’s and procedure for destruction of obsolete
SOP's at -----------------------
3.0
RESPONSIBILITY:
3.1
Officer/Designee or above (Originating Department) - Preparation of SOP’s.
3.2
Department Head (Originating Department) - Reviewing of SOP’s.
3.3
QA Manager / Designee - Approval of SOP’s.
3.4
Plant Head / GM – Authorization of SOP’s.
3.5
QA (Quality Assurance) Personnel - For control, issuance, retrieval and
destruction of SOP’s.
4.0
ACCOUNTABILITY:
The Accountability of implementation and compliance of
the SOP is of respective Department Head & QA Head.
5.0
PROCEDURE:
5.1
Instructions:
5.1.1
All SOP’s shall be written and prepared in the
format given in F/QA-001-01.
5.1.2
All SOP’s shall be written in English language
as all the technicians, Supervisor, Officers and Managers are expected to
follow English to implement and execute.
5.1.3
The language used in SOP shall be clear,
instructive, sequential and unambiguous.
5.1.4
In case the user is directly doing activity and
is not able to read or understand English, the SOP shall be translated in Hindi
language also.
5.2
Body of SOP: All SOP’s have following sequence.
5.2.1
OBJECTIVE:
Every SOP shall explain the purpose for
which the Standard Operating Procedure is prepared.
5.2.2
SCOPE:
Every SOP shall indicate where the Standard Operating
Procedure is applicable.
5.2.3
RESPONSIBILITY:
Every Standard Operating Procedure shall indicate the position/department responsible for
implementing the respective procedure.
5.2.4
ACCOUNTABILITY:
Every SOP shall explain in
detail who is accountable for the implementation and compliance of SOP.
5.2.5
PROCEDURE:
5.2.5.1 Every SOP
shall explain in detail the procedure to be followed and the records to be
maintained to demonstrate that SOP is being implemented.
5.2.5.2 The
Procedure of SOP shall be written in simple language, understandable by user.
The procedure shall cover all activities of operation in order and area of
application mentioned in scope. Start the procedure from precautions, if available,
then followed with instructions for procedure.
5.2.5.3 Precaution: The
detailed precaution should be mentioned. This can include the safety measure to
be adopted while carrying out the activity. This may also include the statement
of warning, which may affect the overall activity. If no such precautions are
applicable, directly start with activity stepwise.
5.2.5.4 Acceptance Criteria and Frequency: After
completion of the activity, the criteria on the basis of which that activity
will be considered complete and the acceptance level will be mentioned. If
there is no such criteria directly go for next step frequency if repetition of
activity other then mentions frequency.
5.2.5.5 Wherever
necessary, Notes, References, Annexures, Flow Charts, and Drawings or
Definitions shall be added to bring clarity to Standard Operating Procedure.
5.2.6
LIST OF ANNEXURE AND FORMATS:
Every Standard Operating
Procedure shall indicate the annexures and formats to be followed, as
applicable.
5.2.7
REFERENCE:
Every Standard Operating
Procedure shall indicate references.
5.2.8
REVISION HISTORY:
Every Standard Operating Procedure shall explain the revision details in the last
page including Effective Date, Revision No., Reason for Revision and Type of
Revision.
5.2.9
ABBREVIATIONS:
Every Standard Operating
Procedure shall explain the abbreviations details in the last page including Sr.
No., Abbreviations and detailed meaning of abbreviations used in the SOP.
‘’END OF DOCUMENT’’
NOTE: Cleaning, calibration services,
maintenance, safety shall be dealt in the Standard Operating Procedure, wherever required and shall be the part of
the procedure.
Equipment/Instrument Number shall be covered in the
scope including the name/model of the Equipment/Instrument.
5.3
In procedure if activity is divided in steps, each step must be in bold
letter.
5.3.1
THE HEADER OF STANDARD OPERATING
PROCEDURE MUST HAVE:
Each page of standard operating procedure consists of
header at the top as shown in format No.: F/QA-001/01 and details as mentioned
below:
(a)
All characters of
header are to be mentioned in bold fonts.
(b)
The header
consists of 7 rows. Rows no 2, 3, 7 consist no column where as row no. 1
consist 3 columns and row no. 4, 5, 6 consist 2 columns.
(c)
In first row, the
name of the Organization (including name & location) in Bold Letter of 11
font size in ‘’Times New Roman’’ with “Logo” of Organization in left corner on
top followed by “Standard Operating Procedure” in centre written in bold and
capital letter of the line spacing between sub-heading and first line of
content should be 6pt.
(d)
In second row,
the subject of the document i.e. Standard Operating Procedure (SOP) should be
written.
(e)
In third row, the
title of Corresponding SOP is to be mentioned.
(f)
In the first
column of fourth row mention SOP No. as described in section 5.6.1
(g)
In second column
of fourth row write page number: The “page numbering” for the SOP shall be done
in the format “Page x of y” at the designated place in the Header. Only the SOP
shall be given page numbers in a sequential manner, however, the annexure /
format to the SOP shall be page numbered individually e.g. Format F/QA-001-01,
Annexure A/QA-001-01
(h)
In the first and
second column of fifth row, mention effective date and review date respectively
as describe in section 5.6.4
(i)
In the first and
second column of sixth row, mention previous and new version.
(j)
In the seventh
row, mention originating dept from which the SOP has been originated /
initiated.
5.3.2
SOP NO.: Allocate different identification
number as follows: SOP-XX-YYY.
Each number consists of
10 characters.
First 3 characters indicates
Standard Operating Procedure
4th Characters is
‘-‘dash.
5th & 6th Characters
indicates department Code.
7th Characters is
‘-‘dash.
Last 3 Characters are numerical which indicate
the sequential number commencing at 001 for each department. The department
code for all departments shall be given below:
|
Sr. No. |
Department |
Code |
|
1.
|
Quality Assurance |
QA |
|
2.
|
Quality Control |
QC |
|
3.
|
Engineering |
EG |
|
4.
|
Personnel & Administration |
PA |
|
5.
|
Production (Tablet) |
PT |
|
6.
|
Production (Capsule) |
PC |
|
7.
|
Production (Ointment) |
PO |
|
8.
|
Warehouse (RM/PM/FG) |
WH |
5.3.3
PAGE NO.: Written as X of Y, where X is
sequential page number and Y is total number of pages and also a provision for
“Space For Master Copy Stamp” shall
be provided to stamp the “Master Copy” in
green colour.
5.3.4
EFFECTIVE DATE: This date mentions the day on which SOP
is implemented for any particular Operation.
5.3.5
NEXT REVIEW DATE: The SOP shall have review date after
two years from the effective date.
Note: If there is no change in SOP, during the periodic review, it shall be
reprinted incorporating the revised effective date / review date, revision
number and the reason of review as ‘Periodic review’.
5.3.6
EFFECTIVE / REVIEW DATE:
(a) An “Effective Date” in DD/MM/YY
format (e.g. 01/11/20 for 1st Nov 2020) shall be assigned to each
SOP, after taking into consideration the necessary training period and creating
awareness to all concerned prior to effective date.
(b) A “Review Date” in DD/MM/YY format
(e.g. 31/10/22 for 31st Oct. 2022) shall be assigned to each
Standard Operating Procedure.
5.3.7
Next Review Date: The SOP shall have review date after
two years from the effective date. The Review
shall be completed within 30 days from the previous review month
5.3.8
REVISION NO.: The New version of SOP shall be
written, as ‘R0’ has to be registered. It is revision then subsequent revision
no. has to be given e.g. ‘R1’, ‘R2’.
5.3.9
SUPERSEDES SOP NO.: This section shall have previous SOP
number along with revision number. e.g. SOP-QA-001 shall come in category of
superseded and shall be mentioned as SOP-QA-001/R1.
5.3.10 THE FOOTER OF STANDARD OPERATING PROCEDURE MUST HAVE:
I.
PREPARED BY: Person of the Originating Department shall
Sign and Date.
II.
REVIEWED BY: Head of the Originating Department shall
Sign and Date.
III.
APPROVED BY: Quality Assurance Manager or, his/her
designee shall approve all SOP’s.
IV.
AUTHORIZED BY: Plant Head / GM shall authorize all SOP’s.
Note: The name and designation of each of the above mentioned participating
person must be printed. All SOP’s
shall be printed in Black ink and Prepared By, Reviewed By, Approved By, Authorized
By & all the Signatures / Date in master should be done in Blue colour ball
pen only. Also a provision for “Stamp”
shall be provided to stamp the information as described in the step 5.18 to
5.26, as applicable.
5.4
All points in the SOP shall be numbered sequentially. Similarly the
sub-paragraphs of each point shall also be numbered sub sequentially, with an
increasing number derived from the heading number.
For example if the heading number is 1, the sub
heading shall have sequentially number as 1.1, 1.2, 1.3 and so on. Each step
under the sub heading 1.1 shall be numbered as 1.1.1, 1.1.2 and so on. In case
where numbering of sub paragraphs is not necessary, and listing is essential,
bullets or other suitable identification marks may be used to illustrate the
same.
5.5
The following is the procedure for giving Format Number to SOP.
Format No.: F/XX-YYY-01
Each number consists of 11 characters.
(a)
In format first character F indicates ‘’Format’’
(b)
2nd characters is ‘/’.
(c)
3rd & 4th character indicates department code
to which to which the SOP belong to as described in step 5.6.1.
(d)
5th characters is ‘-‘dash.
(e)
6th, 7th & 8th characters indicate
the serial number of SOP to which format belongs.
(f)
9th character is ‘-‘dash.
(g)
Last 2 characters 10th & 11th are numerical which
indicate the serial number commencing from 01 for each format.
5.6
A SOP shall be neatly typed using a computer (Microsoft Word) and printed
in black ink on A4 size white paper (on one side of the paper only).
5.7
The font type and font size of the printed letters, including Header and
Footer, shall be uniform (Times New Roman 11), except where bold text is
required as in case of Header, Headings and note.
5.8
For the SOP typing, the following page setup / word formatting details
may be used preferably:
·
Top/
Bottom Margins = 0.5 inch
·
Left
and Right Margins = 0.5 inch & 0.5 inch
·
Gutter
0 inch (from left) Header/Footer
·
Line
spacing = Single, Heading/ Subheading = Bold letters
·
Paragraph
spacing (before & after) = 6 Points
5.9
The Last page of the Standard Operating Procedure should have, in
addition to the above “End of Document”.
5.10
The SOP shall be initiated by Officer/ Executive of concerned department.
The draft of SOP shall be discussed with a group comprising of Operating
Manager, QA Head & Head of other departments.
5.11
The draft copy of Standard Operating Procedure shall be finally discussed
in the meeting coordinated by Quality Assurance along with concerned
Production, Engineering, and Quality Control Department after discussion and adding suggestion given by the
concerned persons from Engineering, Production, Quality Control and Quality
Assurance.
5.12
Take the final print out of Standard Operating Procedure and signed by
all concern and shall be authorized by Plant Head / GM. Authorized copy shall
be treated as “Master Copy”. Master copy should remain with Head of Quality
Assurance Department in the Master SOP file. An electronic copy of all current
and historical SOP’s shall be maintained by Head of Quality Assurance
Department.
5.13
Quality Assurance and Head of the Department will jointly organize for training on
the SOP to concerned departmental employee within 2 weeks from the Date of
authorization. A written evaluation shall be made of the training imparted to
employees by Quality Assurance as per Standard Operating Procedure SOP-QA- 002 “Training of employees”.
5.14
The written evaluation record of all SOP training record is kept with HR
department.
5.15
QA Officer / Executive shall
receive the request for required SOP in “Requisition
for SOP Issuance” requisition Format No. F/QA-001-02 duly signed with
reason for the requirement.
5.16
The SOP Issuance Requisition shall be approved by concerned Department
Head or his designee and authorized by QA Head or his Designee.
5.17
After getting the authorization for issuance the distribution of SOP are
recorded in the “SOP Distribution and Retrieval
Record” as per format no F/QA-001-03 and allotted a unique number.
5.18
Required photocopies of Master Standard Operating Procedure shall be made
and copy shall be stamped with the following information in the specified
column with type of copy at the bottom of the right hand side of the footer
under the heading “Stamp” filling
the required details and duly signed by Quality Assurance person.
5.19
Procedure of Display Copy No.: Allocate different identification
number as follows: @@/SOP-XXX
Each number consists of 10 characters.
(a) First 2 characters indicates Department Code
(b) 3rd Characters is ‘/‘.slash
(c) 4th Characters indicates SOP
(d) 5th Characters is ‘-‘dash.
(e) Last 3 Characters are Numerical which indicate the sequential
number commencing at 001 for each department.
|
Sr. No |
Type of Copy |
Color |
Stamp |
||
|
1.
|
Master Copy |
Green |
|
||
|
2.
|
Display Copy |
Red |
|
||
|
3.
|
Controlled Copy |
Blue |
|
||
|
4.
|
Uncontrolled Copy |
Black |
|
||
|
5.
|
Obsolete Copy |
Red |
|
5.20
If the document is required to be given to an outside agency, a photocopy
of the Master Copy shall be made with the permission of the Head of Quality
Assurance. Each page of each copy shall be stamped with the following information in black ink at the bottom
of the right hand side of the footer under the heading “Stamp” of the document and duly signed by Quality Assurance
personnel.
5.21
REVISION OF THE STANDARD
OPERATING PROCEDURE
5.21.1 Frequency: All SOPs revision 2 year ±30 Days
5.21.2 Standard
Operating Procedure shall be reviewed on or before due date of review (i.e. 2 year
±1 Month from the effective date) by following the step 5.7.6 of this Standard
Operating Procedure.
5.21.3 A Standard Operating
Procedure shall be reviewed whenever there is any change which has potential
impact on quality, safety, efficacy of the product.
5.21.4 Any
person wishing to revise a Standard Operating Procedure (With Department Head
Approval) will request for a “Change Control Requisition Form” from the
Quality Assurance Department. The Quality Assurance personnel will issue a controlled
copy of the “Change Control Requisition Form” with sign and date
5.21.5
The Display Copies of the new
revised SOP will be issued for display as per the procedure. All the Display
copies of previous Standard Operating Procedure shall be collected by Head of
Quality Assurance Department / designee before distributing / issuing Standard
Operating Procedure.
Note: The obsolete copies of SOP shall be destroyed
by shredding.
5.21.6
In situations where SOP has to be issued
outside the department for any reason whatsoever, the same shall be issued as Controlled
Copy.
5.21.7
The previous Standard Operating
Procedure shall be destroyed and number of copies destroyed shall be recorded
in the “SOP Distribution and Retrieval Record” as per format no F/QA-001-03.
The SOP distribution record will be maintained along with Superseded SOP.
5.21.8
DELETION OF STANDARD OPERATING PROCEDURE:
A.
The Master copy should be deleted
mentioning “SUPERSEDED” and shall be maintained in a “Redundant Standard Operating
Procedure” file. The Standard Operating Procedure may also be reviewed before
Due Date of Review because of a change in process, utility, change in
specification and method of testing.
B.
A Standard Operating Procedure
shall be deleted in following circumstances but not limited to:
·
Equipment/system/utility/instrument is
not in use i.e. Discontinued.
·
Equipment/system/utility/instrument is
transferred to another area.
·
However, the same SOP number shall not
be allotted to any newly created SOP.
C.
Any person wishing to delete a Standard
Operating Procedure (With approval of Department Head) will request for a “Change
Control Requisition Form” from the Head of Quality Assurance Department. The Head of Quality Assurance
Department/designee will issue a copy to concern department of the current
revision of the Standard Operating
Procedure with the “Change Control Form” attached indicating “Deletion”.
D.
The “Change control Form” will be
routed for approvals. Approval of the deletion will be indicated by signature
and date on the “Change Control Form”.
E.
Once the deletion has been approved
by the Head of Quality Assurance Department, then a date will be assigned by
the Head of Quality Assurance Department as deletion date. Then all the
distributed copies are withdrawn / retrieved from the distributed location by
the QA Officer / Designee.
F.
SOP Number of deleted document will
not be reused after deletion of the document. The distributed copy of the
deleted document will be retrieved back and same will be destroyed and number
of copies destroyed shall be recorded in the “SOP Distribution and Retrival
Record” as per format no F/QA-001-03.
G.
The Master copy of the deleted document should be defaced mentioning, “Obsolete Copy” on all the pages including formats in red ink at
the centre of the document and it is to be maintained in “Obsolete Document File”.
H.
Such obsolete copies shall be
maintained for history.
5.21.9 LIST OF FORMATS:
All
related formats shall be tabulated as below:-
|
Sr. No. |
Title of Format |
Format No. |
|
1.
|
------------------------------------- |
------------------------ |
The
entire format should be in the specified header only as per the format and
should not contain footer.
5.21.10REVISION HISTORY:
All changes/revision
(addition/deletion) in the sop shall be reflected in the “Revision Details”.
Shall be tabulated as below:
|
Effective Date |
Revision No. |
Reason for Revision |
Type of Revision |
|
|
|
|
|
The dates which
are pre-printed shall be mentioned in DD/MM/YY Manner. The type of
revision as Periodic Review / Interim Review / Need Base whichever is applicable.
In case of new SOP,
it shall be written as “New SOP” in Type of Revision and mention ‘R0’ in the
revision no column & “New SOP” in reason for revision column.
6.0
LIST OF FORMATS:
|
Sr. No. |
Title of Format |
Format No. |
|
1.
|
SOP Format |
F/QA-001-01 |
|
2.
|
Requisition for SOP Issuance |
F/QA-001-02 |
|
3.
|
SOP Distribution and retrieval
record |
F/QA-001-03 |
|
4.
|
SOP Index |
F/QA-001-04 |
7.0
REFERENCE:
8.0
REVISION HISTORY:
|
Effective Date |
Revision No. |
Reason for Revision |
Type of Revision |
|
|
9.0
ABBREVIATIONS:
|
Sr. No. |
Abbreviations |
Details |
|
1.
|
SOP |
Standard
Operating Procedure |
|
2.
|
NA |
Not
Applicable |
|
3.
|
QA |
Quality Assurance |
|
4.
|
GM |
General Manager |
|
5.
|
QC |
Quality Control |
|
6.
|
DEPT. |
Department |
|
7.
|
Sr. No. |
Serial Number |
|
8.
|
RM |
Raw Material |
|
9.
|
PM |
Packing Material |
|
10.
|
HOD |
Head of Department |
END OF DOCUMENT
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