SWISS Pharmaceuticals (Pvt.

)
Ltd. Karachi, Pakistan.

Document No.

QAD/D&RC/SOP/002

Effective Date

01/06/2010

Revision No.

SOP FOR SOP WRITING

Prepared by

Rev:
Dated:

Replaces

Reviewed by

QAI

00

In-Charge QA

Approved & Authorized by

Q.A. Manager

1.0 Purpose
The purpose of this SOP is to provide guidelines for preparing SOPs
2.0 Scope
This SOP is intended to use as a guidelines for the preparation of all SOPs of the
Pharmaceuticals (Pvt.) Ltd. Karachi, Pakistan.

SWISS

3.0 Terms and Definitions

Terms

Definitions

SOP

Standard Operating Procedure

4.0 Responsibilities
a.

Quality Assurance Manager

i.
To manage and supervise the preparation/ writing of SOPs according to this procedure.
ii.
To sign each and every controlled document of the Factory as an approving authority, and
sign the SOPs of QA and QC Department as an approving and authorizing authority.

b.

Departmental Head
i.
To review the SOPs of their department and as an evidence of review.
ii.
To implement the SOPs of their department
iii.
To maintain, update the SOPs according to relevant procedure

c.

Section Incharge
i. To write the SOPs according to this procedure.
ii. To conduct trainings of their Staff and Workers in case of implementation of new SOP or
any change in the existing SOP.

5.0 Environment, Safety and Health Precautions

a.
To minimize the wastage of paper.
b.
Environment, Safety & Health Aspects should be incorporated in all SOPs where applicable.
c.
To discard all the obsolete documents according to procedure.
6.0 Procedures
a.
Standard Format
For writing an SOP, follow the standard format of SOP, the standard format comprises into following
12 portions
i.
ii.
iii.
Copy #

Header
Footer
Purpose
Page
Controlled Copy: Not to be duplicated

of 5 - 1 -1-1-1-

SWISS Pharmaceuticals
(Pvt.) Ltd. Karachi, Pakistan.

Document No.

QAD/D&RC/SOP/002

Effective Date

01/06/2010

Revision No.

SOP FOR SOP WRITING

iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
xii.

00
Rev:
Dated:

Replaces

Scope
Terms and Definitions
Responsibilities
Environment, Safety and Health Precautions
Procedure
References
Records
History
Distribution List

i.
Header of SOP
Follow the unique pattern of header for writing any SOP, header provides the following
information
a.
Company Logo
b.
Company Name
c.
Document Title
d.
Document No.
e.
Effective Date
f.
Revision No.
g.
Replaces and
h.
Authorized Signatures i.e. prepared by, reviewed by, approved by and authorized by.
Only the header of first page having authorizes signature, other pages of SOP should
have same information but authorized signatures are not required.
ii.
a.
b.
c.

Footer of SOP
Footer of SOPs should have the following
Copy No.
Controlled Copy: Not to be duplicated
Page Nos i.e. Page 1 of 10, Page 2 of 10 ..

iii.

Purpose
The Purpose Section clarifies the principal objective subject of SOP. The purpose of
the SOP should relates and expend well written title. Expand or qualify the directive
language used in the title (e.g. To describe the cleaning procedure of Syrup Filling
Machine)

iv.

Scope
Scope should provide the limits to the use of procedure, i.e. identify the intended use
and/ or activity where the SOP may be relevant. State to what areas this SOP does
apply and does not apply.

v.

Terms and Definitions

Identify and define terms use in this SOP. Provide addition and/ or relevant
information needed to under stand this SOP. Explain the abbreviations in this section.

vi.

Responsibilities
Who is responsible for performing the work described?
Who is responsible for implementing the procedure?

Copy #

Controlled Copy: Not to be duplicated

Page

of 5

SWISS Pharmaceuticals
(Pvt.) Ltd. Karachi, Pakistan.

Document No.

QAD/D&RC/SOP/002

Effective Date

01/06/2010

Revision No.

SOP FOR SOP WRITING

00
Rev:
Dated:

Replaces

vii.

Environment, Safety and Health Precautions

In this section identify and describe the preventive measures to be taken in response
of any suspected Environment, Safety and Health hazard.

viii.

Procedure
Describe the procedure in step by step, chronological manner. Use active verbs and
direct statements (e.g. check the cleanliness of area and machines)

ix.

Reference
Provide the Document No. and Description of document as a reference of any official
book, any standard, any guidelines i.e. GMP guidelines, WHO guidelines, ICH
guidelines or the reference of in-house SOPs. If no reference is required mention Not
Applicable

x.

Records
Provide Document No. and Description of document of any record generated after
following the procedure and other record relevant to this procedure. If there is no
record mention Not Applicable

xi.

History
In this portion mention the reason of new revision to maintain the history of various
revisions of SOP.

xii.

Distribution
Distribute the SOP to the concerned and relevant persons of the Factor, mention the
Copy No., Designation of the receiver of the copy and get signed upon issuing the
copy. Master Document having original signatures must be Copy No. 1 and it is
archived in D&RC Section of QA Department, required number of copies of the SOP is
made according to the distribution list. To control unauthorized copying stamp all the
copies of SOP with red ink, as
DO NOT COPY
Authorized Copy if this
STAMP is RED
Copy No.
b.
SOP Indexing Format
A unique SOP number is assigned to each SOP using a specific format. The format of indexing
scheme is as follow:

Copy #

XXX/YYY/SOP/NNN
XXX identifies the Department
YYY identifies the Section.
NNN Identifies the Next Consecutive Number

Controlled Copy: Not to be duplicated

Page

of 5

SWISS Pharmaceuticals
(Pvt.) Ltd. Karachi, Pakistan.

Document No.

QAD/D&RC/SOP/002

Effective Date

01/06/2010

Revision No.

SOP FOR SOP WRITING

00
Rev:
Dated:

Replaces

c.

SOP Development
SOP should be prepared by concerned supervisor/ Officer/ Section Incharge and
reviewed by the concerned Manager, approved by the QA/QC Manager and authorized
by the Factory Manager. Whereas the SOPs of QA/ QC Department to be approved
and authorized by the QA/ QC manager.

d.

Frequency of Revision and reviews

SOPs need to remain current to be useful. Therefore whenever the procedures are
changed SOPs should be updated and reviewed. If desired, modify only the pertinent
section of SOP and indicate the revision No. effective date and briefly describe the
cause of change in History section of the SOP.
All SOPs to be update after every three years from the effective date of last revision
to ensure that the policies and procedures remain current and appropriate.

e.

Implementation of SOP
The most important step for implementing the SOP in working area, train or retain the
user, every one should follow the procedure exactly with each and every step in
detail, it is very essential to train the user otherwise individual may interpret meaning
in different ways.
While training the user trainer should share the reason WHY, SOP must performed
correctly. People are much more to follow when they understand importance of
procedure .Trainer should explain and demonstrate how each step in the SOP will be
performed and should assure them this will increase Quality of product by providing
safety and accuracy which will ultimately increase the confidence of the user.
Keeping in view the following consideration during SOP writing:

i.

Completeness: The SOP should be written with all necessary information required to
implement the system. There should not be any point left that may create any
misunderstanding or confusion.

ii.

Conciseness: The SOP should be written with short and compact sentence for easy
understanding and implementation. The SOP should be avoided with unnecessary
repetition of words or sentences.

iii.

Consideration: The SOP should be concentrated to any specific activity.

iv.

Concreteness: The SOP should be effective and convincing for true implementation of
the system.

v.

Clarity: The SOP should be written with clear and known words and abbreviations.

vi.

Courtesy: The SOP should not be written that implicates dictation or any discrimination
rather it should be written that implicates positive attention.

Copy #

Controlled Copy: Not to be duplicated

Page

of 5

SWISS Pharmaceuticals
(Pvt.) Ltd. Karachi, Pakistan.

Document No.

QAD/D&RC/SOP/002

Effective Date

01/06/2010

Revision No.

SOP FOR SOP WRITING

00
Rev:
Dated:

Replaces

vii. Correctness: The SOP should be written using right level of language, with accuracy
of facts, figures and words and maintaining acceptable writing mechanism.
7.0 References
Document No.

Description

QAD/D&RC/SOP/001

Working of Documentation and Record Control Section

8.0 Records
Document No.

Description

QA/D&RC/QF/001

Document Change Request Form

QA/D&RC/QF/002

Document Review Register

9.0 History
Revision No.
00

Description
New SOP

10.0 Distribution List

The followings are in Controlled Distribution List.
Copy No.

Designation

Copy # 01

Master Document

Copy # 02

Factory Manager

Copy # 03

Quality Assurance Manager

Issued To
D&RC

Note: When a revision of the SOP is issued, the obsolete version should be returned back to
Management Representative for disposal.

Copy #

Controlled Copy: Not to be duplicated

Page

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