STANDARD OPERATING PROCEDURE

Preparation, review, approval, control and revision of

Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 1 of 8

1.0 OBJECTIVE
To lay down a procedure for the preparation, review, approval, control, and
revision of Standard Operating Procedure document.

2.0 SCOPE
This procedure is applicable to all operations of VB MEDICARE Private
Limited.

3.0 RESPONSIBILITY
3.1 User department shall prepare the SOPs.
3.2 User Department Head or designee shall review the SOPs.
3.3 Quality Assurance department shall control, issue and retrieve the SOPs.
3.4 Head-Quality Assurance or designee is responsible for the implementation /
compliance.

4.0 DEFINITION(s)
Not Applicable

5.0 PROCEDURE
5.1 The following procedure shall be followed for the preparation of a SOP.
5.1.1 All SOPs shall prepare as per the standard format as per the annexure
:VBQA/SOP/01/A01.
5.1.2 All SOPs shall be written in clear, instructive in English language.
5.1.3 All SOPs shall be printed on “A4” size white paper in black in “Times New
Roman” regular font style of size “12” unless specified.
5.1.4 There shall be a single line space before starting of text on each page of the
SOP and before each heading.
5.1.5 Right hand side of header shall have the company’s logo. The font for heading
‘Standard Operating Procedure’ shall be “Times New Roman” with size “16”
in capitals and for the rest of the text it shall be regular case with size “12”.
5.1.6 Content of the Footer shall have a regular font style of “Times New Roman” in
capitals for column titles, in the title case for “User Department / Head of the
Department /Quality Assurance”. The size of the font shall be “12”.
5.1.7 Each Standard Operating Procedure shall have a header on every page. Each
header, in addition to that mentioned under 5.1.5, shall have a Title, SOP No,
Department, Effective Date, and Page No.

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00
 STANDARD OPERATING PROCEDURE
Preparation, review, approval, control and revision of
Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 2 of 8

5.2 The information to be entered in the header shall be as detailed below.

5.2.1 Title
Title of the Standard Operating Procedure shall be mentioned in bold in
sentence case so as to indicate the contents / activity.
5.2.2 SOP No.
This is a unique number allotted to each SOP by Quality Assurance. Once
allotted it cannot be allotted to any other SOP.
5.2.3 This is an alphanumeric number consisting of 14 characters.
For example, the first SOP prepared for Quality Assurance Department in the
V.B Medicare Private Limited shall be numbered as VBQA/SOP/01-00.
5.2.4 The first 2 alphabetical characters ‘VB’ represent the Company name.
5.2.5 Next (3 to 4) alphabetical characters ‘QA’ represents Department name.
5.2.6 The 5th character ‘/’ is a forward slash as separator.
5.2.7 The 6 to 8 character ‘SOP’ represents the Standard Operating Procedure.
5.2.8 The 9th character ‘/’ is a forward slash as separator.
5.2.9 The 10th and 11th character denotes sop serial number for particular department.
5.2.10 The 12th character denotes”–“ as separator.
5.2.11 The last two characters denote the version number of the sop starting with ‘00’
and continuing serially in increments of one unit.
5.3 All the headings and sub-headings along with the serial numbers shall be in
bold and in capital letters for headings and sentence case for sub-headings. All
SOPs shall have following sections on Objective, Scope, Responsibility,
Definition, Procedure, Reference, Abbreviations, and Annexure(s).
5.4 If there is no description / explanation under sub-headings ‘Definition’ or
‘Reference’ or ‘Abbreviation’ or ‘Annexure’ in the SOP, then the words “Not
Applicable” shall be indicated.
5.5 The following details shall be given under each heading:
5.5.1 Objective
The objective of writing of the respective Standard Operating Procedure shall
be mentioned and it shall start with words “To lay down”. An overview of the
intent of the SOP shall be briefly mentioned here.
5.5.2 Scope
The extent, to which the SOP is applicable, like areas / personnel / equipment /
process, shall be mentioned.
5.5.3 Responsibility
The designation and the department directly responsible for the activity
mentioned in objective of respective SOP shall be mentioned.

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00
 STANDARD OPERATING PROCEDURE
Preparation, review, approval, control and revision of
Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 3 of 8

5.5.4 Definition
Definitions of technical /scientific terms used in the SOP shall be included.
5.5.6 Procedure
The activities to be carried out as a part of SOP shall be described. The
sentences of the procedures shall be short, unambiguous, sequential, clear and
in instructive language.
5.5.7 Reference (s)
List of all SOPs referred shall be mentioned along with SOP number and title.
5.5.8 Abbreviation (s)
List of standard Abbreviation (s) / Acronym (s) used in the SOP shall be
mentioned along with expansion.
5.5.9 Annexure (s)
A list of annexure(s) described in the SOP shall be listed along with the
annexure number, detail / title and format number.
5.6 Numbering system for Annexure: This is an alphanumerical number consists
of 15 characters.
For example, Annexure 1 for this SOP shall be numbered as
VBQA/SOP/01/A01.
5.6.1 The first 2 alphabetical characters ‘VB’ represent the Company name.
5.6.2 Next (3 to 4) alphabetical characters ‘QA’ represents Quality Assurance
Department name.
5.6.3 The 5th character ‘/’ is a forward slash as separator.
5.6.4 The 6 to 8 character ‘SOP’ represents the Standard Operating Procedure.
5.6.5 The 9th character ‘/’ is a forward slash as separator.
5.6.6 The 10th and 11th character denotes the SOP number.
5.6.7 The 12th character ‘/’ is a forward slash as separator.
5.6.8 The next three characters (13 to15) 13th character “A” denotes annexure and
starts with “01” denotes serial number of the annexure of that particular SOP.
5.6.9 Annexure: Each Annexure to be used for recording shall have unique format
number for control. Annexure meant for reference purposes only shall not
have any format number.
5.6.10 Annexure attached to SOP shall be stamped as ‘SPECIMEN’ with sign and ate
by Quality Assurance.
5.6.11 Numbering system of Format: This is an alphanumerical numbers consist of
18characters. For example, Format number for Annexure 1 of this SOP shall
be numbered as VBQA/SOP/01/F01-00
5.6.12 The first 2 alphabetical characters ‘VB’ represent the Company name.
5.6.13 Next (3 to 4) alphabetical characters ‘QA’ represents Department name.
5.6.14 The 5th character ‘/’ is a forward slash as separator.

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00
 STANDARD OPERATING PROCEDURE
Preparation, review, approval, control and revision of
Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 4 of 8

5.6.15 The 6 to 8 character ‘SOP’ represents the Standard Operating Procedure.

5.6.16 The 9th character ‘/’ is a forward slash as separator.
5.6.17 The10th and 11th character denotes the SOP number.
5.6.18 The 12th character ‘/’ is a forward slash as separator. The ‘F01’ represent the
the format number for that particular SOP for that department.
5.6.19 The 16th character’– ‘denotes the separator.
5.6.20 The last two characters denote revision number of the format.
5.7 Department
Name of the department to which the SOP pertains shall be mentioned in full /
expanded form.
5.8 Effective Date
This indicates the implementation date of the respective SOP. It shall be
dated in dd-mm-yyyy format. e.g.1st of January 2009 shall be written 01-01-
2009.
5.9 The initiator or his HOD shall communicate the effective date after the
approval of the SOP to the Quality Assurance. Training of the respective
SOP shall be imparted to all concerned personnel before being made
effective.
5.10 Page No.
This is written in ‘page X of Y’ format where ‘X’ indicates page number and
‘Y’ indicates total number of pages of the main SOP excluding annexures. For
Example : page 2 of 3 indicates second page out of the total 3 pages.
5.11 Each SOP shall have footer on every page having column for Prepared By,
Reviewed By and Approved By along with Sign/Date. Each column shall have
information mentioned as below.
5.12 Prepared By
This column shall bear the signature of the person who has prepared the SOP
along with the date.The user shall prepare the SOP.
5.13 Reviewed By
This column shall bear the signature of the person who has checked / reviewed
the SOP along with the date. The user department HOD shall review the SOP.
5.14 Approved By
This column shall bear the signature of the person who has approved the SOP
along with the date.
5.15 Head QA or designee shall approve the SOP.
5.16 Preparation of a new SOP
5.16.1 User shall prepare a draft copy of SOP and put ‘DRAFT COPY’ and shall circulate
to the user departments and QA for review.

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00
 STANDARD OPERATING PROCEDURE
Preparation, review, approval, control and revision of
Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 5 of 8

5.16.2 Upon receipt of draft copy the reviewer shall review and send comments to the
user for incorporating the same in the final copy.
5.16.3 After incorporation of suggestion(s) as applicable the SOP shall be forwarded for
signatures and approval. User shall destroy the draft copy by shredding after the
approval of the SOP and record the same in the Distribution slip (Annexure
VBQA/SOP/01/A05.).
5.16.4 The user department shall forward the approved copy of SOP along with the
updated softcopy of the SOP to the Documentation Assurance for control and
distribution along with Distribution slip (Annexure VBQA/SOP/01/A05.).
5.17 Preparation of SOP index
5.17.1 A register shall be maintained by every department as per annexure,
VBQA/SOP/01/A03 indicating the current issue in use and status of the superseded
and obsolete documents.
5.17.2 A “” mark shall be made to indicate the current version in use.
5.17.3 A “” mark shall be made to make the version as superseded.
eg: If 04 version is current then a “” is out in 04 version. When 05 versions
comes in to effect the earlier version is marked by diagonally crossing the box
.X.Each department shall prepare the updated list of SOP index as per
annexure VBQA/SOP/01/A04
5.18 Control of standard operating procedure
5.18.1 User department shall raise SOP Requisition/Distribution slip, get it approved
by Quality Assurance Department. (Annexure VBQA/SOP/01/A05).
5.18.2 The review date of all the SOPs shall be for a period of two years from the
effective date.
5.18.3 The original copy of the respective SOP shall be retained by Quality Assurance
department as master copy.
5.18.4 Quality Assurance department shall arrange for the photocopies for distribution
based on the request made in the SOP requisition/distribution slip. (Annexure
VBQA/SOP/01/A05)
5.18.5 Quality Assurance department shall issue the photocopy of the master as controlled
/ uncontrolled copy (ies).
5.18.6 For controlled copies: Photocopy of the master copy shall stamped with a
“CONTROLLED COPY ” on every page across the text matter in the body. These
shall be issued to the user departments only.
5.18.7 For uncontrolled copies: photocopy of the master copy shall be taken with a
“UNCONTROLLED COPY” on every page across the text matter in the body.
Quality Assurance shall approve these requests.
5.18.8 Quality Assurance shall do control, issue and retrieval of all the SOPs.

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00
 STANDARD OPERATING PROCEDURE
Preparation, review, approval, control and revision of
Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 6 of 8

5.19 Issuance and retrieval of standard operating procedure

5.19.1 Quality Assurance department shall maintain the record for the issue, control,
retrieval and destruction of superseded copy of SOP and the same shall be recorded
in the format (Annexure VBQA/SOP/01/A06).
5.19.2 SOP shall be issued to concerned department by Quality Assurance Department
only after training is conducted and the concerned department. Issuance shall be as
per the approved distribution slip and Quality Assurance shall take signature from
the receiver in the record mentioned above.
5.19.3 The existing SOP, if revised, then all the existing controlled copies of SOP shall be
retrieved and forwarded to Quality Assurance by concerned department / Quality
Assurance department.
5.19.4 Upon receipt of retrieved copy, Quality Assurance shall record and destroy the
retrieved copy (ies) by shredding and maintain the record for the same.
5.19.5 Quality Assurance shall put a stamp “SUPERSEDED COPY” in red on the text of
each page of the master copy of that SOP and same shall be recorded in the format
(Annexure: VBQA/SOP/01/A06).
5.19.6 Issuance record of uncontrolled copy shall be maintained in the Issuance Record
(Annexure: VBQA/SOP/01/A07).
5.19.7 The revised version of the Standard Operating Procedure shall be controlled and
issued by Quality Assurance department.
5.19.8 If any Standard Operating Procedure is to be made obsolete the change control
procedure shall be followed.
5.19.9 Initiator department shall raise the change control with necessary justification and
after approval of the Change Control by Quality Assurance Department the
Standard Operating Procedure shall be made obsolete by the Quality Assurance
Department.
5.19.10 Quality Assurance shall put a stamp “OBSOLETE COPY” in red on the text of
each page of the master copy of that SOP.
5.19.11 All superseded and obsolete versions of SOPs shall be chronologically filed and
stored separately by the Quality Assurance.
5.20 Revision of standard operating procedure.
5.20.1 SOP shall be reviewed once in every two years by the initiating department.
5.20.2 A Change Request Note shall be raised for the changes that are desired / deemed
necessary in the existing procedure.
5.20.3 User department shall raise a ‘Change Request Note’ as per SOP on ‘Change
control system’, which shall be approved as per change control procedure.
5.20.4 After approval of Change Request Note, initiator shall prepare the SOP as per the
above-mentioned procedure.

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00
 STANDARD OPERATING PROCEDURE
Preparation, review, approval, control and revision of
Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 7 of 8

5.20.5 All the changes made in the revised SOP shall be entered in brief in the ‘Change
History’ and attached at the end of the SOP. (Annexure VBQA/SOP/01/A09)
Note: Change history shall indicate all the changes associated with each of the
version.
5.21 Routine review:
5.21.1 If there are no changes during the routine / mandatory review, each department
shall forward a note to Quality Assurance indicating the same along with the
justification for adequacy of existing procedure.
5.21.2 Change history for that SOP shall be revised mentioning ‘Review done - No
changes required’ under the column changes made and approved in a same way as
SOP.
5.21.3 Revised and approved change history shall be issued to the user departments.
5.21.4 Old copies of the change history shall be returned by the user department and
destroyed by the Quality Assurance.
5.21.5 Issuance and destruction records shall be maintained.
5.21.6 The validity of the SOP is extended for next two years from the date of approval of
the change history form.
5.21.7 SOP validity extension shall be done only once. At the end of the extended validity
period, the SOP shall be revised for routine review.
5.21.8 If there is a change in the annexure, which does not result in any change in the text
of the SOP, then the SOP for Preparation, review and control of formats SOP shall
be followed.

6.0 REFERENCE(s)

SOP No. Title

(Current Version)
VBQA/SOP/07-01 Change Control System.

7.0 ABBREVIATION(s)
Abbreviation Full Description
SOP Standard Operating Procedure
No. Number
e.g. Example

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00
 STANDARD OPERATING PROCEDURE
Preparation, review, approval, control and revision of
Title: Standard Operating Procedures.

SOP No: VBQA/SOP/01-00 Department Quality Assurance

Effective Date: 02.01.2009 Page No: Page 8 of 8

8.0 ANNEXURE(s)
Annexure No. Details/Title of Annexure Format No.
(Current version)
VBQA/SOP/01/A01 Format for Standard Operating Procedure. VBQA/SOP/01/F01-00
VBQA/SOP/01/A02 Format for Department codes for SOP VBQA/SOP/01/F02-00
Numbering System.
VBQA/SOP/01/A03 Format of register for List of SOPs. VBQA/SOP/01/F03-00

VBQA/SOP/01/A04 Format for SOP requisition / distribution VBQA/SOP/01/F04-00

slip.
VBQA/SOP/01/A05 Format for SOP issuance and retrieval VBQA/SOP/01/F05-00
record.
VBQA/SOP/01/A06 Format for SOP issuance record for VBQA/SOP/01/F06-00
uncontrolled copy (ies).
VBQA/SOP/01/A07 Format of SOP Index. VBQA/SOP/01/F07-00
VBQA/SOP/01/A08 Format of Flow Chart . VBQA/SOP/01/F08-00
VBQA/SOP/01/A09 Format of Change History. VBQA/SOP/01/F09-00

PREPARED BY REVIEWED BY APPROVED BY

User Department Head of the Department Quality Assurance/Designee

Sign: Sign: Sign:

Date: Date: Date:
VBQA/SOP/01/F01-00