No WP6_Q_1001.3 Version No. 3
Name of Author
Sign and Date
Name of Assistant
Manager Quality Assurance
Sign and Date
Name of Quality
Sign and Date
Name of Head of Quality
Sign and Date
procedure is a guidance on how to prepare, number, retain, index, revise and
format the Standard Operating Procedure (SOP) documents. This SOP is for
authors who write the SOPs.
methods and procedures are described in detail in SOP to maintain the quality
and integrity of the data and processes. SOPs are created to provide step wise
guidance to the technical and administrative end users, reviewers and approvers
of their roles and responsibility to help them perform in a better way. Authoring
of SOP in correct way is important. A SOP should follow a standard format for
ease of understanding throughout organization.
the need of SOP by personnel in the department
the immediate supervisor of the department about the need of SOP
the Quality Assurance Manager the need of SOP
should write the SOP in a way that all the steps to be followed are clearly mentioned
in the SOP
should be reviewed by one or multiple reviewers as required
should be directly related to the SOP or from department who may be affected
due to the SOP being prepared.
department in charge of SOP and QA manager should review the SOP. QA manager
should assure that the SOP documents what are the actions to be followed when a
SOP is not being followed correctly.
manager checks the uniformity and format of the SOP document and lifecycle
management of the SOP
the need to make or revise a SOP and intimate immediate supervisor of the same.
the SOP who is responsible for the procedure.
the draft copy of the SOP to other individuals in the department who directly
related or involved in the procedure for their review.
the final draft SOP to QA manager for approval of the SOP.
of the SOP document should be the same throughout the document for font, font
size, color, numbering and margins.
should mention the SOP no, SOP Title, Revision date, Supersedes, Effective Date
and Page no
title page should include Names of author, reviewers and approvers along with
sign and date.
document should have Table of contents with correct headings and numberings.
Section to be included in SOP are as
below mentioned in Table 1. List of
Sections to be included in SOPs:
Table 1 List of Sections
to be included in SOPs:
Summary of the
Health and Safety
Equipment and Supplies
Data and Record
assurance and Quality Control
SOP belongs to a specific category maintained by the QA. Each SOP has unique
manager determines the category to which the SOP belongs and assigns the number
to the SOP.
of categories are
General and Administrative
Validation of the Procedures
Lifecycle Management of SOPs
Record maintenance of Trainees
of QA manager is to list the SOP in the main List of all SOPs in Quality data
errors will not be subjected to revision of SOP number.
in procedure, addition or deletion to SOP will require full review of the SOP
and approval and will be assigned a revised SOP number.
department in charge of SOP should request to eliminate the previous SOP before
making the revised SOP effective.
SOP which are no more required should be archived for future references.
directly related or departments affected due to change should trained well
before the effective date of the SOP.
records should be maintained in a repository for future reference.
the step wise procedure should be followed as mentioned in the SOP
deviation to the SOP should be documented.
to SOP deviation should be provided to QA.
action plan should be executed.
approved signed SOPs belonging to the department should be placed in the SOP
drawer belonging to the QA manager.
drawer should be allowed to use by the QA manager and QA Head of the Department
signed SOP and its other revised SOPs are archived and maintained by QA manager.
a new procedure is incorporated into another SOP a copy of superseded version
is also included in the binder on the archived SOP.
Assurance and Quality Control
the SOP every 3 years to update any information which needs modification.
which do not require any change should be justified to QA and approval for the
same is to be received.
1. Quality Manual of BEST
MEDICINE LABORATORIES Version 3.1
for Preparing Standard Operating Procedures (SOPs) EPA QA/G-6
Editorial changes and typo errors