BEST
MEDICINE LABORATORY

 

SOP
No WP6_Q_1001.3 Version No. 3

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January
21, 2018

 

 

AUTHORED BY:

Kasturi
Haldankar

 

Name of Author

Sign and Date

REVIWED BY:

Premchand
Naik

 

Name of Assistant
Manager Quality Assurance

Sign and Date

APPROVED:

Robert
Mark

 

Name of Quality
Assurance Manager

Sign and Date

Anna
Holland

 

Name of Head of Quality
Assurance Department

Sign and Date

 

 

 

I.                  
Purpose
and Applicability:

This
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.

 

II.               
Summary:

Study
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.

 

III.            
Definitions:

 

 

 

 

 

 

 

IV.            
Responsibility:

 

1.      Identify
the need of SOP by personnel in the department

2.      Inform
the immediate supervisor of the department about the need of SOP

3.      Intimate
the Quality Assurance Manager the need of SOP

4.      Author
should write the SOP in a way that all the steps to be followed are clearly mentioned
in the SOP

5.      SOP
should be reviewed by one or multiple reviewers as required

6.      Reviewers
should be directly related to the SOP or from department who may be affected
due to the SOP being prepared.

7.      The
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.

8.      QA
manager checks the uniformity and format of the SOP document and lifecycle
management of the SOP

 

V.               
Procedure:

 

a.     
Preparing
SOPs

1.      Identify
the need to make or revise a SOP and intimate immediate supervisor of the same.

2.      Author
the SOP who is responsible for the procedure.

3.      Send
the draft copy of the SOP to other individuals in the department who directly
related or involved in the procedure for their review.

4.      Send
the final draft SOP to QA manager for approval of the SOP.

5.      Format
of the SOP document should be the same throughout the document for font, font
size, color, numbering and margins.

6.      Header
should mention the SOP no, SOP Title, Revision date, Supersedes, Effective Date
and Page no

7.      The
title page should include Names of author, reviewers and approvers along with
sign and date.

8.      SOP
document should have Table of contents with correct headings and numberings.

9.     
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:

 

 

Administrative
SOPs

Technical SOPs

Purpose

Yes

Yes

Summary of the
procedure

Yes

Yes

Definitions

Yes

Yes

Responsibilities

Yes

Yes

Qualifications

Not required

Yes

Health and Safety
Warnings

Not required

Yes

Cautions

Not required

Yes

Equipment and Supplies

Not required

Yes

Procedure

Not required

Yes

Data and Record
Management

Yes

Yes

Quality
assurance and Quality Control

Yes

Yes

References

Yes

Yes

 

b.     
Numbering
of SOP:

 

1.      Each
SOP belongs to a specific category maintained by the QA. Each SOP has unique
number assigned.

2.      QA
manager determines the category to which the SOP belongs and assigns the number
to the SOP.

3.      List
of categories are

 

 

Category

1000-1999

General and Administrative

2000-2999

Laboratory procedures

3000-3999

Validation of the Procedures

4000-4999

Lifecycle Management of SOPs

5000-5999

Record maintenance of Trainees

6000-6999

Miscellaneous

 

c.       Indexing
the SOP:

1.      Responsibility
of QA manager is to list the SOP in the main List of all SOPs in Quality data
management document/manual.

 

d.      Revising
SOPs:

1.      Typo
errors will not be subjected to revision of SOP number.

2.      Change
in procedure, addition or deletion to SOP will require full review of the SOP
and approval and will be assigned a revised SOP number.

3.      The
department in charge of SOP should request to eliminate the previous SOP before
making the revised SOP effective.

4.      The
SOP which are no more required should be archived for future references.

 

e.       Using
SOPs

1.      Individuals
directly related or departments affected due to change should trained well
before the effective date of the SOP.

2.      Training
records should be maintained in a repository for future reference.

3.      All
the step wise procedure should be followed as mentioned in the SOP

4.      Any
deviation to the SOP should be documented.

5.      Justification
to SOP deviation should be provided to QA.

6.      Corrective
action plan should be executed.

 

VI.            
Management
of Record

a.       Location
of SOP

1.      All
approved signed SOPs belonging to the department should be placed in the SOP
drawer belonging to the QA manager.

2.      SOP
drawer should be allowed to use by the QA manager and QA Head of the Department
only.

b.      SOP
Retention:

1.      Original
signed SOP and its other revised SOPs are archived and maintained by QA manager.

2.      If
a new procedure is incorporated into another SOP a copy of superseded version
is also included in the binder on the archived SOP.

 

VII.         
Quality
Assurance and Quality Control

1.      Review
the SOP every 3 years to update any information which needs modification.

2.      SOPs
which do not require any change should be justified to QA and approval for the
same is to be received.

 

VIII.      
Reference

1.      Quality Manual of BEST
MEDICINE LABORATORIES Version 3.1

2.      Guidance
for Preparing Standard Operating Procedures (SOPs) EPA QA/G-6

 

IX.            
Revision
Record:

 

SOP
No.

Revision
Date

Description
of change

Responsible
person

A-1001.1

01/15/2016

Initial Release

John Smith

A-1001.2

03/05/2017

Editorial changes and typo errors
changes performed

Joh Smith

 

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