International Journal of Applied Ayurved Research ISSN: 2347- 6362

STANDARD OPERATING PROCEDURE (SOP) WRITING MADE

EASY
Thakur Sudarshan K.1, Tak Anjna2, Phull Gaurav3, Phull Rekha4.
1
M.D.Ras Shastra and Bhaishajya Kalpana, Senior Consultant, National Institute of
Ayurvedic Pharmaceutical Research, CCRAS, Patiala. Punjab. India.
2
M.D. Prasooti Tantra and Stri Roga, Associate. Professor of Prasuti Tantra & Stree Roga,
Abhilashi Ayurvedic College & Research Institute, Mandi, H.P, India.
3
M.S. Shalya (Sangyaharan) Clinical Registrar Sangyaharan, CBPACS, New Delhi,India
4
M.D. Kaya Chikitsa, Lecturer Kayachikitsa, MLRA College, Charkhi Dadri, Hayana, India.
ABSTRACT :
Documentation is an essential activity conducted in all the scientific and technical establish-
ments/agencies. The process of documentation has changed a lot with time and became more
and more scientific and professional. Now a day any organization for getting any authority or
certification like International Organization for Standardization (ISO), should have quality
standard documentation of all the activities going on in its premises or network. In spite of
having a sound understanding of the ethics, activities and quality policies, writing a SOP may
look to be time consuming and complex task. This article is tailored specially to provide a
ready format for writing a SOP. This review paper highlights important areas of considera-
tions and steps forwards in a sequential manner to reduce the possibilities of errors. By fol-
lowing these steps in a chronological manner one may easily write a SOP on any activity or
operation to ensure good practices in any organization especially in a department involving
technical activities.
Key words: Documentation, SOP, Standard Operating Procedure, Standardization, format,
SOP format.
INTRODUCTION: Standard documenta- quality services or end products. Here is a
tion is a vital activity in a genuine and cer- compilation of points, practiced now a day
tified organization. These standard docu- to write SOP with all possible allowable
ments may be named differently in differ- variants under any heading. These variants
ent fields, organizations or work places but may be used and altered, molded, shuffled
the word SOP; standard Operating proce- or edited to meet the needs of that particu-
dure is the most common name used for lar organization. Also SOP is also not a
this. This SOP is documentation of an op- static document; it needs continuous revi-
eration or activity, describing what and sion, updation, and replacement from time
how it is done. The SOP refers to opera- to time. This revision protocol has also
tion and maintenance of equipments or been explained in this review.
objects and activities in an organization Standard operating procedure is a written
and further the documentation describing a document that describes,
manufacturing process is named Master 1.A specific procedure or set of procedures
Formulae. so established1,2.
Though every organization may have dif- 2.Established procedure to be followed in
ferent requirements but all have a common carrying out a given operation in given sit-
goal to provide error free and uniform uation1,2.
 [Thakur Sudarshan K et al :Standard Operating Procedure (Sop) Writing Made Easy]

3.To lay down a procedure for the prepa- 5.Head Quality Assurance
ration, approval, authorization, control and Department/Site Head/General
revision of standard operating procedure3. 7
Manager :Authorization, Distribution,
4.Step by step information on how to exe- Control and Retrieval of SOPs, also
cute a task4. Ensuring Preparation, Review, Training
5.The procedure that must be followed to and Implementation cycle to follow.
carry out operation5. FORMAT OF SOP:SOPs shall follow a
OBJECTIVE:To lay down a procedure scientific format, and are written with the
for the preparation, approval, authoriza- view that they will be used by persons
tion, control and revision of standard oper- trained in the procedure11. So to prepare a
ating procedure3 also6,7,8; new format these guidelines may be
1.To ensure compliance standards are met. followed;
2.To ensure everything goes according to 1.Format from regularity authority.
schedule. 2.Pre-existing format of organization.
3.To prevent failures in manufacturing. 3.A simple step format; it is just a bullet
4.To ensure safety. list of simple sentences telling the reader
5.To maximize production. what to do4.
6.To prevent any adverse effect on the en- 4.Hierarchical Steps format: For long
vironment. Procedures, involving few decisions to
7.To be used as training material. make, clarifications and terminology4.
SCOPE:This sop is applicable to; 5.Flow chart format: - More like map4.
i. All SOPs7,9,10. 6.Newly developed format: A new format
ii. Department/Section/Area)8,9,10. to suit the requirement of
iii. Standard operating procedures and as- equipment/procedure/department/site. May
sociated records of actions taken or, where include a combination of all formats
appropriate, conclusions reached should be having simple sentences,flow charts,
available for various activities in the tables, pictures and or diagrams.
organisation and for manufacturing The formats and sample SOPs can be used,
process. modified, or redesigned, according to
iv. Preparation and implementation of organizational structure, and by the
Master formula. Manufacturing process complexity of their manufacturing
documents should be called as Master operations11.
formula rather than SOP as per WHO FORMAT REQUIREMENTS
GMP guidelines11,12. Language
RESPONSIBILITY: Though, pharmaceutical documents are
1.Designee7:Preparation, Revision, primarily written in English language
Periodic Review, Training, owing to WHO GMP preferred language.
Implementation. But If required, some of the sops shall be
2.Operator: Review, Implementation. written in local language3 in copies along
3.Executive/Supervisor:Periodic Review, with the language preferred by the
Training, Implementation. regulating authority. Considering your
4.Head of Department:Checking, user/audience4 from workers, operators,
Approval, Conducting Training and supervisor and executives up to regulatory
Implementation of SOP5. authority is necessary. While opting
799 www.ijaar.in IJAAR VOLUME II ISSUE 6 MAR-APR 2016
 [Thakur Sudarshan K et al :Standard Operating Procedure (Sop) Writing Made Easy]

English language, the type of font for the mentioned here and in case of new SOP it
contents in sops shall be ‘Times New is marked as “NEW INTRODUCTION”3.
Roman’. The text font size to be used and REVIEW DATE (2YEAR -2 MONTHS);
layout of contents of sops shall be as Though it is considered exactly 2 years
detailed in table 13. Though, organizations after effective date of SOP3,4,5 yearly11; but
may develop their own standards keeping practically, as maximum 2 months5 are
in view regulatory authority guidelines. permissible for review of a SOP, Review
Parts and Contents of SOP As per layout date 2 years minus 2 month is justified so
of pages, all SOP's shall consist of ; - that review duration may not be a period
1.Header without effective SOP. Revision No is
2.Body/Content represented as; 00: - New SOP, 01: - first
3.Footer revision, 02: - Second revision and so on.
1.Header: Header part of the SOP should 11.NAME WITH DASIGNATION,
remain common for all pages excluding SIGNATURE & DATE : In blue ink3 of;
format and annexure5; a.PREPARED BY: Who wrote the SOP.
It may have following contents; Actual Operator/Supervisor5 of equipment
1.NAME OF INSTITUTE/ or procedure and in case of SOP of SOP
ORGANISATION/COMPANY AND (SOP No. 001 i.e. Preparation, approval,
PLACE. Authorization, Control and Revision of
2.LOGO OF ORGANISATION. sops, person best know about SOP writing
3.STANDARD OPERATING should prepare SOP.
PROCEDURE b.CHECKED BY : Person who is really
6.TITLE OF SOP: through the subject, Department in-charge
e.g. Standard operating procedure for usually5.
cleaning/operation/maintenance of c.APPROVED BY:By two authorities5;
equipment with equipment number. i.Head of concerned Department and
5.DEPARTMENT:Eg.Production/Quality ii.Head Quality Assurance.
Assurance etc. In case of QA SOPs, first approval shall be
6.LEVEL5:-e.g. 0, 1 or 2 ; done by Assistant Manager and above
1. Level “0” : - Instruments/ Equipment authority and second approval by Manager
Procedures related to each Department. and above of quality Assurance3.
2. Level “1” : - General procedures of d.AUTHORIZED BY : (The person
each department. finally authorizing the SOP i.e. Head
3. Level “2”:Organization Policy. QA/QC/Location Head/ Regulatory)5.
7.SOP NO. : e.g. NPP/PG/SOP000-00 In case of QA SOPs, location QA Head
8.COPY NO. :It is represented e.g. As shall authorize all the SOPs except3 the
“Copy No. 02 of 08”. SOP No. 001(i.e. Preparation, approval,
9.EFFECTIVE DATE: Means this SOP Authorization, Control and Revision of
starts with effect from dated; and this date sops), This SOP shall be authorized by
is stamped by QA/Head Works3, after final Vice President of Corporate QA3.
authorization process. The protocol may be followed with
10.SUPERSEDES: Previous/Obsolete equivalent to above authorities in different
SOP No. With Effective Date should be organizations.

800 www.ijaar.in IJAAR VOLUME II ISSUE 6 MAR-APR 2016

 [Thakur Sudarshan K et al :Standard Operating Procedure (Sop) Writing Made Easy]

1.BODY/CONTENT: It Should have IDENTIFICATION NUMBER:There

following contents; are also the identification systems or codes
OBJECTIVE/PORPOSE: This section devised to number and track both
must mention the intended use and information and documents. These are
applicability of SOP. It must start with SOP numbers, equipment numbers, form
letter “To” and must be one sentence or numbers, receiving codes, and batch/lot
maximum two sentences statement only5. numbers. These numbering systems should
2.SCOPE:This sop is applicable to; be designed so that procedures, processes
i. ..Documents/machine/procedure of and materials can be traced throughout the
ii. Department/Section/Area) data records11.
3.RESPONSIBILITY: SOP No:
I. Designee II. Operator III. Supervisor. 1.16 Character SOP No.3.e.g.
4.ACOUNTABILITY:Head of NPP/PG/SOP001-00 ( N. Pharmaceuticals
Department. Place/Production General /SOP001-
5.PROCEDURE: Primary contents; 00Revision No.)
a.Clear, concise, chronological8,11, • Relating with above example; First two
procedure details should be mentioned. characters denotes Organization Name,
b.SOP shall be written in active voice, e.g. NP is N. Pharmaceuticals.
command verbs4, as instruction8. •Third character denotes site, e.g. P for
c.Comprehensive flow chart, picture, Place.
design and examples for calculation8,11 and • Fourth character is Slash (/).
how to do, if possible (not to make it •Fifth and sixth character denotes
lengthy but to keep it short. Department or Section code e.g. PG for
d.Frequency, Special precaution and safety Production General and QA for Quality
considerations must be discussed. Assurance, WH for Warehouse etc.
e.All possible deviation should be written. • Seventh character, is slash (/)
REFERENCES : The references, cross- • Eight ,ninth and tenth characters, denotes
references like SOPs, machinery or "SOP''
equipment manuals, books, guidelines, •Eleventh, Twelfth & Thirteenth characters
acts or online references and abbreviations denotes serial number of SOP, starting
used shall be elaborated at the end of from "001"onwards.
respective SOP. • Fourteenth character is dash (-).
ANNEXURES: Format, tables etc to fill, • Last two characters denote Revision No
machinery or equipment manuals, charts, of SOP.e.g. First new SOP of QA shall
diagram, flow chart etc. Linked to SOP. have SOP number as NPP/QA/SOP001-
ABBREVIATIONS:All the abbreviations 00.2.8 character sop no.5.E.g. PP001-00
used in the document shall be tabulated. (Pharmaceuticals Production
SOP DISTRIBUTION5:Details of 00100Revision No.)
distribution and retrieval of SOP with copy 3.7 character SOP no.3.e.g. PPP-001 (Place
no. And date shall be recorded. Table 2 Pharmaceuticals Production-001).
DOCUMENT REVISION HISTORY3: FORMAT NO.3: The format number used
Table 3 for preparing the SOP is mentioned in the
FOOTER: It should have; footer block. The font size of the format
Format number no. Shall be in Times New Roman Font:
801 www.ijaar.in IJAAR VOLUME II ISSUE 6 MAR-APR 2016
 [Thakur Sudarshan K et al :Standard Operating Procedure (Sop) Writing Made Easy]

10, Style: Regular. The format numbering 11.Submitted to QA department as original

system shall be as follows: Format number Copy (stamped as Master Copy) along
shall consist of total sixteen characters3. 3
with change history log . Kept in strict
e.g. NPP/PG001/F01-00; (N. supervision of Head QA5.
Pharmaceuticals Place/Production General 12.Draft copy destroyed3,5.
001/Format01-00Revision No.). {Decoded 13.Training5.
like SOP No.}. Here 001 is SOP number to 14.Issuance of SOP5 (as photocopies of
which the format is linked, F is Format, Master copy) by QA department to
rest all is explained like SOP No. This respective department Stamped as
format number shall appear on all the “CONTROL COPY”.
SOPs. 15.Implementation4,5.
EQUIPMENT NO.:A in house coding 16.Further Review intermittent or
protocol may be followed to ensure scheduled.
uniformity and avoiding repetition of 17.Retrieval of old (previously issued)
number coding. , like SOP NO. e. g. copies from respective
5
NPP/PG/EQP001-00. Here EQP :- departments .
Equipment and rest all can be explained STAMPING/MARKING OF SOP: To
like SOP No. mark the sops during the development
PROTOCOL TO FOLLOW TO process or distribution, SOP is stamped
GENERATE AND REVIEW SOP3,5 usually on Top Right5 as;
(cycle time not more that 7 days)5. And MASTER COPY : - Red Colour5
total maximum time with training and CONTROL COPY : - Blue Colour5
implementation two months5. OBSOLETE : - Blue Colour5
Steps: DRAFT COPY : - Blue Colour3
1. Draft of SOP by user department9. ENSURING SUCCESS AND
2. Draft copy stamped/watermarked on ACCURACY IN DEVELOPING SOP4:
each page3. 1.Writer of SOP:Usually the initial draft
3. Discussed and Tested on; of an SOP is written by the person
i. Not known to procedure/Machine4 ii. performing the procedure or by someone
Actual user/worker4. who knows the procedure well.
4. Corrections done (if required). Supervisors review the SOPs for
5. Sent to reviewing authority3,4,5. completeness and content and QC or QA
(DepartmentHead/QA/QC/Regulatory5,10). staff approve for regulatory compliance11.
6. Any comments evaluated by the 2.Test The Procedure4: It is best to have
department head and incorporated in draft a handful of people test your SOP. But
copy (if necessary5. ensure the person representative of normal
7. Corrected Final copy printed on the reader with positive attitude for the success
approved format5. or work. Here also first of all test on a
8. Sent (along with change history log) [3] person who has never done it before so
for Approval and Authorization. that his prior knowledge may not help
9.Approval and Authorization done and him.Secondly test with the actual
signed by all concerned5. worker/supervisor4.
10.Back in User Department

802 www.ijaar.in IJAAR VOLUME II ISSUE 6 MAR-APR 2016

 [Thakur Sudarshan K et al :Standard Operating Procedure (Sop) Writing Made Easy]

3.Review of SOP: Have the SOP reviewed v. The newly revised SOP shall go
by the advisor/Head and quality assurance through same process of Authorization as
team4. generation of sops.
4.Authorization Protocol: Strict ABBREVIATIONS:
authorization protocol to follow. 1. SOP : -Standard Operative Procedures.
5.Training of Worker/Supervisors: 2. EQ. No. : - Equipment No.
Practically most important aspect to 3. WHO : - World Health Organization.
remove the fear to use new document and 4. i.e. :- That is.
so successful SOP implementation. 5. GMP : Good Manufacturing Practices.
Authority: - QA department. 6. e.g. :- For Example.
Training Coordinator/Organizer: - Head 7. SOP :- Standard Operative Procedure.
of Department5. 8. NP :- N Pharmaceuticals.
Training record is kept. 9. PG :- Production General
6.Issuance, Control and Retrieval of 10. P :- Production
SOP: 11. QC :- Quality Control.
Responsibility: Document section, QA 12. F :- Format
department. 13. TNR :- Time New Roman.
It should be done with necessary entries in 14. B :- Bold.
SOP distribution/review and retrieval 15. U :- Upper Case
record documents5. ANNEXURE:
7.Implementation of SOP: A positive i. Format sop.
environment should be developed about ii. Machine manual.
documentation procedures among actual iii. Sop cleaning/operating machine.
users. Should be more like accepted than iv. Sop regent handling.
forced. v. Standard abbreviations.
8.Revision of SOP: Periodic and as per REFERENCES:
requirement. The document should be 1. thefreedictionary.com [Dictionary on
regularly reviewed and kept up to date12. internet]. (cited on 2016 Feb 02) Available
i. Must be processed as per SOP of fromhttp://www.thefreedictionary.com/sta
“Change Control Procedure”5,11. ndard+operating+procedure .
ii. “Document Change Request Form”5 2. Houghton Mifflin Harcourt Publishing
should be properly filled and signed and Company, American Heritage® Dictionary
attached with the SOP; submitted to of the English Language, Fifth Edition..
Document Section by the respective Published by Houghton Mifflin Harcourt
department. Publishing Company. (Cited on 2016 Feb
iii. All old copies of SOP, must be returned 02). [Reference on internet]. Available
to document section for reconciliation and from:http://www.thefreedictionary.com/sta
destruction of obsolete copies. ndard+operating+procedure.
iv. Master copy in document section is 3. ChaudharyAnkur.pharmaguideline.com.
marked “Obsolete copy”5 and stored in the [homepage on internet]. 2008. (Cited on
“Obsolete file” along with “document 2016 Feb 02)
change request form”5. from:Http://www.pharmaguideline.com/20
11/07/sop-of-sop.html

803 www.ijaar.in IJAAR VOLUME II ISSUE 6 MAR-APR 2016

 [Thakur Sudarshan K et al :Standard Operating Procedure (Sop) Writing Made Easy]

4. Hadley Chris. wikiHow, 530 Lytton 11. Gillian Chaloner-Larsson, Ph.D, GCL
Avenue, 2nd Floor, Palo Alto, CA 94301 Bioconsult, Ottawa Roger Anderson,
[Wikipedia on internet]. (Cited on 2016 Ph.D, Director of Quality Operations,
Feb 02). Available from: Massachusetts Public Health Biologic
Http://www.wikihow.com/Write-a- Labs Anik Egan, BSc.,GCL Bioconsult,
Standard-Operating-Procedure. Ottawa. A WHO guide to good
5. Manohar A. Potdar. cGMP for manufacturing practice (GMP)
Pharmaceuticals. Medpress publisher. requirements Part 1: Standard operating
2009. procedures and master formulae. chapter 6
6. arora P.L. Pharmaloids Amritsar. page 12. WHO/VSQ/97.01. Printed on
Importance of SOPs. page 8. Monograph; 1997. [Monograph on internet] (Cited on
Workshop on developing SOP’s Herbal 2016 Feb 02). available from:
health research consortium pvt. ltd. http://apps.who.int/iris/bitstream/10665/64
Amritsar. (printed on 2009 Aug 09). 465/1/WHO_VSQ_97.01.pdf
7. Chaudhary 12. Ayush Project. Voluntry Certification
Ankur.pharmaguideline.com. [homepage Scheme for Ayush Products, Certification
on internet]. 2008. (Cited on 2016 Feb 02) Criteria for Ayush Premium Mark, GMP
Available from: requirments 4.4.5.5. [Monograph on
http://www.pharmaguideline.com/2011/05 Internet] (Cited on 2016 Feb 02) Available
/sop-on-standard-operating- from:http://www.qcin.org/PDF/ayush_proj
procedure.html. ect/Certification_Scheme_AYUSH-
8. ChaudharyAnkur.pharmaguideline.com. who4.pdf
[homepage on internet]. 2008. (Cited on
2016 Feb 02) Corresponding Author: Dr. Sudarshan
from:http://www.pharmaguideline.com/20 K. Thakur NIAPR, CCRAS, Moti Bag
08/02/sample-sop-example-sop-sop- Road, Patiala, Punjab, India.
format-sop.html. Email:[email protected]
9. ChaudharyAnkur.pharmaguideline.com.
[homepage on internet]. 2008. (Cited on Source of support: Nil
2016 Feb 02) Available from: Conflict of interest:None
http://www.pharmaguideline.com/2008/01 Declared
/pharma-sops.html.
10. Lachman L. & Lieberman H.A.
Industrial Pharmacy. Special edition 2009.
CBS publisher 2009.
Table 1: FONTS AND LAYOUT OF PAGES3:
Content of SOP (Layout on pages) A4 paper Size of Font
Header
“ORGANISATION NAME” ( on top left corner ) 14 Bold in Upper Case
“STANDARD OPERATING PROCEDURE” & “TITLE” 12 Bold in Upper Case
Logo (on the top, right hand corner) 30 mm (L) x 6 mm(H)

804 www.ijaar.in IJAAR VOLUME II ISSUE 6 MAR-APR 2016

 [Thakur Sudarshan K et al :Standard Operating Procedure (Sop) Writing Made Easy]

“Restricted Circulation” “Pharmaceutical Ltd etc..” “Location”, 10 Bold in Title Case

“Dept.”, “Area”, “Page”, “SOP No.”, “Revision No.” “Effective
Date”, “Supersedes”, “Review Date”, “Initiated By”, “Approved
By”, “Authorized By”, “Name”, “Signature & Date”
Actual Title ( detailed heading ) of SOP 12 Bold in Upper Case
Body
Subheadings 12 Bold in Upper Case
Write up of SOP 12 in Sentence Case
Footer
“Format No.” 10 in Title Case
Actual format number 10 in Upper Case
Table 2; SOP DISTRIBUTION:
Sr. DEPT./SECTION Copy No./Total Retrieval Date Retrieved
No. No.(X) detail by

Table 3; DOCUMENT REVISION HISTORY:

REVION NO./Date EFFECTIVE DATE REASON(REVISION) REVISED BY
00- New Document N.A.(New Introduction)
01 – 1 Revision
st

02 – 2nd Revision
And so on.

805 www.ijaar.in IJAAR VOLUME II ISSUE 6 MAR-APR 2016